Biolox® Delta Ceramic Heads, Biolox® Delta Option Ceramic Heads MR Labeling
Biomet UK Ltd.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002806535 | 3002806535 | BIOMET UK LTD. | 1 | N | 2026-01-01 | WATERTON INDUSTRIAL ESTATE BRIDGEND GB CF31 3XA |
| 9610918 | 3002806539 | Biomet UK Ltd | 1 | N | 2020-04-25 | Dorcan One Hundred Murdock Road Dorcan Industrial Estate Swindon Wiltshire GB SN3 5HY |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00889024683181 | Oxford® Partial Knee System - 112211100 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683198 | Oxford® Partial Knee System - 112211200 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683204 | Oxford® Partial Knee System - 112211300 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683211 | Oxford® Partial Knee System - 112211400 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683228 | Oxford® Partial Knee System - 112211500 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683235 | Oxford® Partial Knee System - 112211600 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683808 | Oxford® Partial Knee System - 512211115 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| 00889024683815 | Oxford® Partial Knee System - 512211150 | +1(800)348-9500 | customerservice@zimmerbiomet.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164558 | 1366094108 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 2004-04-21 |
| 164994 | 1366094108 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 2004-04-21 |
| 164558 | 1995439744 | K833921 | AGC TOTAL KNEE PROSTHESIS | JWH | 1984-01-31 |
| 164558 | 1238320651 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | LZO | 2020-07-29 |
| 164558 | 1853811993 | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | LZO | 2020-02-27 |
| 164558 | 1614332425 | K150522 | G7 Dual Mobility System | LPH | 2015-05-01 |
| 164558 | 1777862216 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | LPH | 2015-02-10 |
| 164558 | 1607255712 | K142746 | G7 Finned Acetabular Shell | LPH | 2014-12-29 |
| 164558 | 1901523452 | K141653 | BIOLOX DELTA CERAMIC OPTION HEADS | LZO | 2014-08-18 |
| 164558 | 1521909742 | K140669 | G7 OSSEOTI ACETUBLAR SHELLS | LPH | 2014-12-11 |
| 164558 | 1675400519 | K131684 | BIOLOX(R) DELTA CERAMIC HEADS | LZO | 2013-10-10 |
| 164558 | 1657174889 | K121874 | G7 ACETABULAR SYSTEM | PBI | 2012-11-23 |
| 164558 | 1127880768 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | 2012-08-17 |
| 164558 | 1591828942 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | 2011-09-30 |
| 164558 | 1655424436 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | 2011-01-21 |
| 164558 | 1865113374 | K101086 | TAPERLOC COMPLETE | KWA | 2010-09-03 |
| 164558 | 1649281083 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | 2010-12-07 |
| 164558 | 1167870464 | K093549 | 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM | LZO | 2009-12-16 |
| 164558 | 1244469860 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | 2010-10-22 |
| 164558 | 1169867466 | K082996 | BIOLOX DELTA OPTION CERAMIC HEADS | LZO | 2009-01-15 |
| 164558 | 1251878449 | K061312 | 36MM BIOLOX DELTA CERAMIC HEADS | LZO | 2006-06-06 |
| 164558 | 1988555461 | K051411 | ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS | LZO | 2005-06-29 |
| 164994 | 2045422251 | K011138 | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT | HRY | 2001-07-10 |
| 164558 | 1008905633 | ||||
| 164994 | 1033681190 | ||||
| 164558 | 1036000770 | ||||
| 164558 | 1185938023 | ||||
| 164558 | 1204863703 | ||||
| 164558 | 1255083793 | ||||
| 164558 | 1353095078 | ||||
| 164994 | 1440533375 | ||||
| 164994 | 1581628234 | ||||
| 164558 | 1594258261 | ||||
| 164994 | 1620162590 | ||||
| 164558 | 1656682756 | ||||
| 164994 | 1656682756 | ||||
| 164994 | 1680921155 | ||||
| 164558 | 1680921155 | ||||
| 164558 | 1684967213 | ||||
| 164558 | 1699964372 | ||||
| 164994 | 1704161287 | ||||
| 164994 | 1718490790 | ||||
| 164994 | 1850079694 | ||||
| 164558 | 1853939915 | ||||
| 164994 | 1865537451 | ||||
| 164558 | 1887716488 | ||||
| 164994 | 1887716488 | ||||
| 164558 | 1897182937 | ||||
| 164994 | 1938242207 | ||||
| 164558 | 1938242207 | ||||
| 164994 | 1958239404 | ||||
| 164558 | 2045841392 | ||||
| 164994 | 2045841392 | ||||
| 164558 | 1033681190 | ||||
| 164558 | 1042886288 | ||||
| 164558 | 1420848131 | ||||
| 164558 | 1440533375 | ||||
| 164558 | 1581628234 | ||||
| 164558 | 1620162590 | ||||
| 164558 | 1718490790 | ||||
| 164558 | 1726208794 | ||||
| 164558 | 1850079694 | ||||
| 164558 | 1865537451 |
2026-04-09
2026-04-09
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03
2026-04-03