TAP HANDLE, A/O STYLE MANUFACTURED BY SMALL BONE INNOVATIONS, INC.

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TAP HANDLE, A/O STYLE

Request for Information Form	Contact Information
Company Name	SMALL BONE INNOVATIONS, INC.
Address	1380 S. PENNSYLVANIA AVE.
City, State, Zip	MORRISVILLE, PA 19067
Country	US
FDA Owner/Operator Phone	212-583-0250
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	HXY
FDA Classification Name	BRACE, DRILL
FDA Device Classification Code	General Controls
FDA Regulation Number	888.4540
FDA Common Generic Name	BRACE, DRILL
FDA Proprietary Device Name	TAP HANDLE, A/O STYLE
FDA Owner / Operator Number	9049474
FDA Owner / Operator Name	SMALL BONE INNOVATIONS, INC.
FDA Establishment Registration Number	3003640913
FDA Registered Establishment Name	SMALL BONE INNOVATIONS, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	05-13-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of SMALL BONE INNOVATIONS, INC.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	DRILL BRACE	VARIOUS MODELS
2	AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US 610-984-9074 / 610-984-9074	DRILL BRACE	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
3	AUGUST REUCHLEN GMBH JUNKERSSTRASSE 8 TUTTLINGEN, D-78532 GM 497-461-96520 / 497-461-96520	BRACE, DRILL	BRACE, DRILL
4	BIO-BRIDGE SCIENCE, INC. 1211 WEST 22ND ST. SUITE 615 OAK BROOK, IL 60523 US 630-928-0869 / 630-928-0869	MULTIPLE	DRILL BRACE
5	BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742	MULTIPLE	VARIOUS TYPES OF BRACE
6	CM INSTRUMENTE GMBH GANSACKER 56 TUTTLINGEN, BW, DE, 78532 GM 49-074-622042061 / 49-074-622042061	CM DRILL BRACE	DRILL BRACE
7	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	CHARNLEY LIGHTWEIGHT BRACE	CHARNLEY LIGHTWEIGHT BRACE
8	DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0	MULTIPLE	VARIOUS MODELS OF BRACES,DRILLS
9	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US 352-377-1140 / 352-377-1140 150	BRACE, DRILL	BRACE, DRILL
10	FALCON SURGICAL CO (PVT) LTD. WAZIRABAD RD., P.O. BOX 134 NEAR VILLAGE GOLOPHALA UGOKI SIALKOT, PK 092-523-510072 / 720-962-5412	MULTIPLE	VARIOUS MODELS OF DRILL BRACES
11	FALCON SURGICAL CO (PVT) LTD. KHADIM ALI RD. P.O. BOX 134 SIALKOT, PUNJAB, 51310 PK 092-523-510072 / 043-2-553428	MULTIPLE	VARIOUS MODELS OF DRILL BRACES
12	G. LEIBINGER MED TECH GMBH BAHNHOFSTR. 59 MUEHLHEIM, D-78570 GM 49-746-399550 / 49-746-399550	BRACE, DRILL	BRACE, DRILL
13	GENERAL SURGICAL CO., (INDIA) PVT. LTD. G-6, GEE GEE CRESCENT 114, POONAMALLEE HIGH ROAD CHENNAI, TAMIL NADU, 600 084 IN 91-44-28233280 / 91-44-28233280	DRILL BRACE	DRILL BRACE ALL TYPES
14	GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900	MULTIPLE	BRACE
15	HOLMED CORP. 40 NORFOLK AVE. SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351	SAME	SAME
16	HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. CHICAGO, IL 60618 US 773-975-6100 / 773-975-6100	VARIOUS	MANUAL DRILL BRACE, SURGICAL, VARIOUS MODELS
17	K2M, INC. 751 MILLER DR.,S.E., SUITE F1 LEESBURG, VA 20175 US 703-777-3155 / 703-777-3155	DRILL GUIDE	DRILL GUIDE
18	MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090	BRACE, DRILL	BRACE, DRILL
19	MEDITRAC MEDICAL EQUIPMENT 53 PINKAS ST. TEL-AVIV, 62261 IS 972-3-5467828 / 760-568-1179	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
20	MILTEX GMBH MUEHLSTRASSE 6 RIETHEIM- WEILHEIM, D-78604 GM 609-275-0500 / 717-840-3409	VARIOUS MODELS ORTHOPEDIC BRACE DRILLS	VARIOUS MODELS ORTHOPEDIC BRACE DRILLS
21	MONDEAL MEDICAL SYSTEMS GMBH MOLTKESTR. 39 TUTTLINGEN, 78532 GM 49-746-1933214 / 858-901-4123	DRILL BRACE (VARIOUS TYPES)	DRILL BRACES
22	MTI MEDIZIN-TECHNISCHE INSTRUMENTE GMBH KRONENSTRASSE 7 TUTTLINGEN, 78532 GM 004-974-619697030 / 004-974-619697030	BRACE, DRILL (MULTIPLE BRANDS)	VARIOUS TYPES OF HAND DRILLS
23	NIC INSTRUMENTS LTD. GLADSTONE RD. FOLKSTONE, KENT, CT19 5NF UK / 013- 03-851022	NO PROPRIETARY NAME LISTED	VARIOUS TYPES BRACE DRILL
24	NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH WEILATTEN 7-9 TUTTLINGEN, 78532 GM 004-974-6294900 / 004-974-6294900	MULTIPLE	VARIOUS
25	O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH 7 SEELANDSTRABE LUBECK, SCHLESWIG-HOLSTEIN, D-23569 GM 49-451-3900626 / 49-451-3900626	BRACE, DRILL	STEP DRILL
26	ORTHO MEDICAL GMBH IMPLANTS HAUPTSTR.5 DUERBHEIM, 78589 GM 074-24-940340 / 497-424-940340	BRACE, DRILL (MULTIPLE BRANDS)	BRACE, DRILL (VARIOUS TYPES)
27	PETER BUMUELLER DREI-KREUZ-STRASSE 31 IRNDORF, 78597 GM 49-74-66-1550 / 49-74-661550	MULTIPLE PRIVATE LABEL	VARIOUS TYPES OF DRILLS
28	PRECIMED SA. L' ECHELETTE 7 ORVIN, 2534 SZ 011-41-32-3580111 / 260-244-6300 204	DRILL BRACE	BRACE, DRILL
29	PRO-NEOTEC LEIBINGER BAHNHOFSTRASSE 59/1 MUEHLHEIM/DONAU, 78570 GM 49-746-3991365 / 49-746-3991365	ORTHOPEDIC DRILL BRACE, VARIOUS TYPES	ORTHOPEDIC DRILL BRACE
30	RZ MEDIZINTECHNIK GMBH UNTER HASSLEN 20 TUTTLINGEN, 78532 GM 49-746-294700 / 49-746-294700	DRILL	DRILL
31	SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 AUSTIN, TX 78751 US 512-206-0770 / 512-206-0770	BRACE, DRILL	DRILL GUIDE
32	STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185	MULTIPLE	VARIOUS TYPES OF BRACES, DRILL, ORTHOPEDIC
33	STUCKENBROCK MEDIZINTECHNIK GMBH LESSINGSTRASSE 50 TUTTLINGEN, 78532 GM 074-61-161114 / 074-611-61114	MULTIPLE	VARIOUS MODELS OF DRILL BRACES
34	SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32	BRACE DRILL ORTHOPEDIC	BRACE DRILL ORTHOPEDIC
35	TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. SATTLERSTRASSE 11 NENDINGEN, TUTTLINGEN-16, D-78532 GM 004-974-61 1701 0 / 004-974-61 1701 0	NO PROPRIETARY NAME LISTED	DRILL, ORTHOPAEDIC
36	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE ORTHOPEDIC DRILL BRACES	VARIOUS TYPES OF ORTHOPEDIC DRILL BRACES
37	TELEFLEX MEDICAL TUTTLINGEN GMBH GAENSAECKER 36 TUTTLINGEN, 78532 GM 919-544-8000 / 919-433-4829	MULTIPLE DRILL BRACES	VARIOUS TYPES OF DRILL BRACES
38	THAEMERT ORTHOPAEDISCHE HILFSMITTEL GMBH & CO. IM STEINKAMP 12 GROSSBURGWEDEL, 30938 GM 51-39-8077-0 / 856-753-5500	EPICONDYLITIS-CLASP	BRACE, ORTHOPEDIC
39	TONTARRA MEDIZINTECHNIK GMBH DAIMLERSTRASSE 15 WURMLINGEN, D-78532 GM 49-746-196576-0 / 49-746-196576-47	BRACE, DRILL (MULTIPLE BRANDS)	BRACE, DRILL (VARIOUS TYPES)
40	VEHU MEDICAL INSTRUMENTE GMBH SEMMELWEISSTR. 48 TUTTLINGEN, 78532 GM 49-746-1163311 / 49-746-1163311	VEHU-MEDICAL GMBH	BRACE, DRILL
41	WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 HAMBURG, 22339 GM / 40-539-95-0 *240	ORTHOPEDIC BRACE DRILL	VARIOUS TYPES
42	WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668	DRILL BRACE	DRILL BRACE
43	WELMED INSTRUMENTS COMPANY DEFENCE RD. NEAR WAPDA GRID COLONY SIALKOT, 51310 PK 92-432-559391 / 410-461-3162	MULTIPLE	VARIOUS TYPES OF DRILL BRACES
44	WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971	MULTIPLE	VARIOUS TYPES OF WIRE AND PIN CUTTERS
45	XINHUA SURGICAL INSTRUMENT CO. LTD. NO. 2 HONGGOU RD. ZHANGDIAN ZIBO SHANDONG, 255027 CH 086-533-2182006 / 630-928-0869	MULTIPLE	DRILL BRACE
46	ZEPF MEDICAL INSTRUMENTS GMBH 21 GUNNINGER ST. SEITINGEN-OBERFLACHT, D-78606 GM 49-746-4 985060 / 497-464-9850625	BRACE, DRILL	BRACE, DRILL
47	ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800	DRILL GUIDE	DRILL GUIDE
48	ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485	MULTIPLE	VARIOUS BRACES FOR REAMERS AND DRILLS