VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
ZIMMER TRABECULAR METAL TECHNOLOGY
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005751028 | 3005751028 | Zimmer Trabecular Metal Technology, Inc. | 1 | N | 2026-01-01 | 10 POMEROY RD. Parsippany NJ US 07054 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00889024310810 | NEXGEN® - 00-5887-056-00 | +1(800)348-2759 | zimmer.consumerrelations@zimmerbiomet.com |
| 00889024316072 | TM Ardis® Trabecular Metal™ - 06-701-06091 | +1(800)348-2759 | zimmer.consumerrelations@zimmer.com |
| 00889024316072 | TM Ardis® Trabecular Metal™ - 06-701-06091 | +1(800)348-2759 | zimmer.consumerrelations@zimmerbiomet.com |
| 00889024316089 | TM Ardis® Trabecular Metal™ - 06-701-06101 | +1(800)348-2759 | zimmer.consumerrelations@zimmer.com |
| 00889024316089 | TM Ardis® Trabecular Metal™ - 06-701-06101 | +1(800)348-2759 | zimmer.consumerrelations@zimmerbiomet.com |
| 00889024316096 | TM Ardis® Trabecular Metal™ - 06-701-06111 | +1(800)348-2759 | zimmer.consumerrelations@zimmer.com |
| 00889024316096 | TM Ardis® Trabecular Metal™ - 06-701-06111 | +1(800)348-2759 | zimmer.consumerrelations@zimmerbiomet.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3881 | 1421425663 | K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | JDI | 2000-03-01 |
| 3881 | 1885577698 | K982751 | IMPLEX SCREW AND WASHER SYSTEM | MBI | 1999-02-01 |
| 3881 | 1126790165 | K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | JDI | 1997-08-06 |
| 3881 | 1624360001 | K962468 | HEDROCEL ACETABULAR RESTRICTOR | JDI | 1997-02-03 |
| 3881 | 1585080687 | K915187 | CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW | HWC | 1991-12-19 |
| 3881 | 1083675185 | K230243 | ROSA® Knee System | OLO | 2023-03-29 |
| 3881 | 1812230988 | K221928 | ROSA® Knee System | OLO | 2022-10-04 |
| 3881 | 1009567224 | K210121 | ROSA Partial Knee System | OLO | 2021-04-19 |
| 3881 | 1292390348 | K191625 | Persona Revision Knee System | JWH | 2019-09-05 |
| 3881 | 1014947090 | K181947 | Persona Revision Knee System | JWH | 2018-10-25 |
| 3881 | 1941588720 | K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | MBH | 2012-06-29 |
| 3881 | 1423302653 | K111119 | TRABECULAR METAL (TM) FUSION DEVICE | ODP | 2011-11-23 |
| 3881 | 1013867002 | K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | MBH | 2011-02-15 |
| 3881 | 1828654717 | K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | MBH | 2010-12-13 |
| 3881 | 1638310661 | K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | KWS | 2007-06-29 |
| 3881 | 1594754629 | K070382 | VISTA -S DEVICE | MQP | 2007-05-30 |
| 3881 | 2025023603 | K061067 | TRABECULAR METAL ACETABULAR AUGMENTS | LPH | 2006-05-25 |
| 3881 | 1831606495 | K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | MBH | 2006-02-27 |
| 3881 | 1199615981 | K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | JWH | 2005-07-27 |
| 3881 | 1986789261 | K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS | LPH | 2005-05-11 |
| 3881 | 1838378968 | K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | HWE | 2005-05-26 |
| 3881 | 1422325305 | K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | HRS | 2005-04-15 |
| 3881 | 1766096355 | K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 | LPH | 2004-12-21 |
| 3881 | 1475184177 | K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | MBH | 2004-12-21 |
| 3881 | 1349138953 | K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | JWH | 2004-01-08 |
| 3881 | 2019840478 | K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | MQP | 2003-07-11 |
| 3881 | 1205203392 | K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | MBH | 2003-08-06 |
| 3881 | 1174508744 | K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS | JWH | 2003-01-15 |
| 3881 | 1344130432 | K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 | JWH | 2002-02-12 |
| 3881 | 1231872388 | K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | JWH | 2001-09-26 |
| 3881 | 1923929903 | K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | JWH | 2001-07-19 |
| 3881 | 1447519519 | K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY | JWH | 2001-01-25 |
| 3881 | 2044764488 | K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ | LPH | 2000-11-07 |
| 3881 | 1797051254 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | JDI | 2000-08-24 |
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ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR METAL TECHNOLOGY
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
ZIMMER TRABECULAR
2016-06-20
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