MULTIPLE MANUFACTURED BY SMITH & NEPHEW ORTHOPAEDICS, GMBH

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MULTIPLE

Request for Information Form	Contact Information
Company Name	SMITH & NEPHEW ORTHOPAEDICS, GMBH
Address	ALEMANNENSTRASSE 14
City, State, Zip	TUTTLINGEN,
Country	GM
FDA Owner/Operator Phone	901-396-2121
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	JEC
FDA Classification Name	COMPONENT, TRACTION, INVASIVE
FDA Device Classification Code	Standards
FDA Regulation Number	888.3040
FDA Common Generic Name	VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1020279
FDA Owner / Operator Name	SMITH & NEPHEW, INC.
FDA Establishment Registration Number	8010764
FDA Registered Establishment Name	SMITH & NEPHEW ORTHOPAEDICS, GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-21-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of SMITH & NEPHEW ORTHOPAEDICS, GMBH

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	ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124 US 503-627-9957 / 503-627-9957 293	SMALL BONE FIXATOR OR SBF	SMALL BONE FIXATOR
2	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	MULTIPLE	VARIOUS
3	ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US 480-763-5300 / 480-763-5350	MULTIPLE	EXTERNAL FIXATION DEVICE
4	AUTOGENESIS, INC. 8700 OLD HARFORD RD. BALTIMORE, MD 21234 US 410-665-2017 / 410-665-2017	AUTOGENESIS AUTOMATOR 2000	AUTOMATIC DISTRACTION COMPONENT FOR EXTERNAL FIXATION DEVICES
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 SKELETAL TRACTION
6	DEPUY ACE S.A.'R.L. RUE GIRARDET 29 CASE POSTALE LE LOCLE, CH-2400 SZ 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
7	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
8	DEPUY-NEW BEDFORD, DIV. OF DEPUY ORTHOPAEDICS INC. NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD, MA 02745 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
9	HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 SACRAMENTO, CA 95825 US 916-923-5073 / 916-923-5073	MULTIPLE	EXTERNAL FIXATOR SYSTEM
10	KARL LEIBINGER GMBH U. CO. KG KOLBINGER STR. 10 MUHLHEIM, D-78570 GM 011-497-463838110 / 800-625-1557	MULTIPLE	COMPONENT, TRACTION, INVASIVE
11	LIMA INTL. CORP. 407 LINCOLN RD, SUITE 10L MIAMI BEACH, FL 33139 US 305-673-6226 / 305-673-6226	LIMA ECS	LIMA CIRCULAR FIXATOR
12	MEDICALPLASTIC VIA MERCADANTE 15 MILANO, 20124 IT / 901-396-2121	MULTIPLE	VARIOUS
13	ORTHOFIX SRL VIA DELLE NAZIONI 9 BUSSOLENGO,VERONA, 37012 IT 394-567-19000 / 39-45-6719000	ORTHOFIX MODULSYSTEM	DYNAMIC AZIAL FIXATION SYSTEM
14	PRECISION MEDICAL DEVICES, INC. 5020 RITTER RD., SUITE 211 MECHANICSBURG, PA 17055 US 717-795-9480 / 717-795-9480	TIBIAL RETRACTOR	TIBIAL RETRACTOR
15	SINTEA BIOTECH SPA VIA AQUILEIA 33/H BARANZATE, 20021 IT 39-02-38204222 / 305-673-6226	SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.	TRAUMAFIX SYSTEM
16	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373	MULTIPLE	VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
17	STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124
18	STRYKER TRAUMA AG BOHNACKERWEG 1 SELZACH, CH-2545 SZ 269-385-2600 / 201-831-5002	MULTIPLE	EXTERNAL FIXATION DEVICE
19	SYNTHES (USA) 35 AIRPORT RD. HORSEHEADS, NY 14845 US 610-719-5000 / 484-356-9728	MULTIPLE	VARIOUS TYPES AND SIZES OF INVASIVE TRACTION COMPONENTS
20	SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728	MULTIPLE	VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE INVASIVE TRACTION COMPONENTS
21	SYNTHES (USA) 1301-1303 GOSHEN PKWY. WEST CHESTER, PA 19380 US 610-719-5000 / 484-356-9728	MULTIPLE	VARIOUS TYPES AND SIZES OF INVASIVE TRACTION COMPONENTS
22	SYNTHES BETTLACH GMBH MURACHERSTRASSE 3 BETTLACH, SO, 2544 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS
23	SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS
24	SYNTHES HAGENDORF GMBH IM BIFANG HAGENDORF, CH-4614 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF TRACTION COMPONENTS
25	TECHRON AG KANALSTRASSE RARON, CH-3942 SZ 027-935-8850 / 484-356-9728	MULTIPLE	VARIOUS
26	WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 HAMBURG, 22339 GM / 40-539-95-0 *240	TRACTION UNIT	TRACTION UNIT
27	ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485	MULTIPLE	MULTIPLE

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