TCR, PCR, SHADOW CR, THREADED CR MANUFACTURED BY WARSAW ORTHOPEDIC, INC.

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TCR, PCR, SHADOW CR, THREADED CR

Request for Information Form	Contact Information
Company Name	WARSAW ORTHOPEDIC, INC.
Address	2500 SILVEUS CROSSING
City, State, Zip	WARSAW, IN 46582
Country	US
FDA Owner/Operator Phone	763-514-4000
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	LZN
FDA Classification Name	CEMENT OBTURATOR
FDA Device Classification Code	Standards
FDA Regulation Number	878.3300
FDA Common Generic Name	CEMENT RESTRICTOR
FDA Proprietary Device Name	TCR, PCR, SHADOW CR, THREADED CR
FDA Owner / Operator Number	2112641
FDA Owner / Operator Name	MEDTRONIC INC.
FDA Establishment Registration Number	1824199
FDA Registered Establishment Name	WARSAW ORTHOPEDIC, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	10-01-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of WARSAW ORTHOPEDIC, 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	BENOIST GIRARD 203 BLVD DE LA GRANDE DELLE BP 8 14201 HEROUVILLE, SAINT CLAIR, 14200 FR 269-385-2600 / 201-831-5002	MULTIPLE	VARIOUS
2	DEPUY CMW CORNFORD RD. BLACKPOOL, LANCASHIRE, FY4 4QQ UK 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
3	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
4	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
5	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US 512-834-6225 / 512-834-6235	CEMSTOP	CEMSTOP
6	HOWMEDICA INTERNATIONAL S. DE R.L., RAHEEN BUSNIESS PARK LIMERICK, EI 269-385-2600 / 201-831-5002	MULTIPLE	VARIOUS
7	HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. MAHWAH, NJ 07430 US 269-385-2600 / 201-831-5002	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
8	ISOTIS NV PROF. BRONKHORSTLAAN 10-D BILTHOVEN, 3723MB NL 412-162-06000 / 310-302-295229	SYSNPLUG	CEMENT RESTRICTOR
9	JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. NO.299, CHANGYANG ST SUZHOU, 215026 CH 574-267-8143 4906 / 574-371-4906	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
10	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	TCR, PCR, SHADOW CR, THREADED CR	CEMENT RESTRICTOR
11	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373	MULTIPLE	VARIOUS TYPES OF CEMENT OBTURATORS
12	STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US 269-385-2600 / 269-323-7700	BIOPREP CEMENT OBTURATOR	OBTURATOR
13	STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI CARRIGTWOHILL INDUST. ESTATE CARRIGTWOHILL COUNTY CORK, EI 269-385-2600 / 201-831-5002	MULTIPLE	OBTURATOR
14	STRYKER PUERTO RICO, LTD. HWY. 3, KM. 131.2 LAS GUASIMAS IND. PARK ARROYO, PR 00714 US 269-385-2600 / 939-307-2606	BIOPREP CEMENT OBTURATOR	OBTURATOR
15	STRYKER SPINE ZONE INDUSTRIELLE DEMARTICOT CESTAS, AQUITAINE, 33610 FR 269-385-2600 / 335-579-70840	MULTIPLE	VARIOUS INSTRUMENTS
16	SUNMEDICA 1661 ZACHI WAY REDDING, CA 96003 US 530-229-1600 / 530-229-1600	CEMENT RESTRICTOR BONE PLUG	ORTHOPLUG
17	TORNIER RUE DOYEN GOSSE ST. ISMIER, 38330 FR 33-765-28000 / 33-04-76613500	TORNIER CEMENT RESTRICTOR	CEMENT RESTRICTOR
18	ZIMMER GMBH SULZER ALLEE 8 WINTERTHUR, CH-8404 SZ / 574-372-4485	MULTIPLE	VARIOUS TYPES AND SIZES OF INTRAMEDULLARY PLUGS, ORTHOPEDIC
19	ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800	CONTINUUM HIP SYSTEM (CHS)	CEMENT RESTRICTOR SYSTEM
20	ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485	MULTIPLE	VARIOUS