Panels › Orthopedic › Product code LZO · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation 888.3353
9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 1992 | K914574 | EXACTECH CERAMIC FEMORAL HEAD COMPONENT Exactech, Inc. | LZO |
| Dec 24, 1991 | K912985 | LIMA 28MM CERAMIC HEAD, MODIFICATION Turnkey Intergration USA, Inc. | LZO |
| Dec 5, 1991 | K914237 | KINAMED CTN STEM Kinamed, Inc. | LZO |
| Nov 27, 1991 | K912641 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS Biopro, Inc. | LZO |
| Nov 22, 1991 | K913633 | TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS Intermedics Orthopedics | LZO |
| Aug 12, 1991 | K912295 | KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL Kinamed, Inc. | LZO |
| Apr 15, 1991 | K905687 | ZIRCONIA CERAMIC MODULAR HEADS Biomet, Inc. | LZO |
| Apr 12, 1991 | K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) Turnkey Intergration USA, Inc. | LZO |
| Apr 9, 1991 | K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) Turnkey Intergration USA, Inc. | LZO |
| Mar 7, 1991 | K905739 | ZIMMER CERAMIC FEMORAL HEADS Zimmer, Inc. | LZO |
| Jan 30, 1991 | K905260 | TOTAL HIP FEMORAL COMPONENT Intermedics Orthopedics | LZO |
| Jan 14, 1991 | K904028 | DCW MODULAR PROXIMAL FEMORAL SYSTEM Dow Corning Wright | LZO |
| Jan 9, 1991 | K903976 | CTH STABILO TOTAL HIP REPLACEMENT SYSTEM Kinamed, Inc. | LZO |
| Aug 9, 1990 | K902712 | OSTEONICS PS HEAD AND NECK HIP STEM SERIES Osteonics Corp. | LZO |
| Jun 8, 1990 | K902074 | KINAMED CEMENTED CTH STEM Kinamed, Inc. | LZO |
| Jun 8, 1990 | K902073 | KINAMED CEMENTED ATH-LONG STEM Kinamed, Inc. | LZO |
| Jun 5, 1990 | K896850 | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE Lima Intl. Corp. | LZO |
| May 9, 1990 | K900628 | MODULAR HIP SYSTEM Richards Medical Co., Inc. | LZO |
| Mar 19, 1990 | K894904 | KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL Kinamed, Inc. | LZO |
| Feb 6, 1990 | K896669 | WEBER PERMALOCK Allo Pro Corp. | LZO |
| Dec 14, 1989 | K895399 | KIM MODULAR FEMORAL HIP PROSTHESIS Dow Corning Wright | LZO |
| Nov 20, 1989 | K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES Richards Medical Co., Inc. | LZO |
| Oct 19, 1989 | K892644 | BIOLOX CERAMIC BALL Allo Pro Corp. | LZO |
| Oct 12, 1989 | K894694 | OMNIFIT CERAMIC MORSE TAPER HEAD Osteonics Corp. | LZO |
| Sep 26, 1989 | K893685 | CERAMIC FEMORAL HEAD Dow Corning Wright | LZO |
| Sep 1, 1989 | K890472 | ATH CERAMIC UHMWPE TOTAL HIP SYSTEM Kinamed, Inc. | LZO |
| Sep 1, 1989 | K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) Richards Medical Co., Inc. | LZO |
| Jun 22, 1989 | K885102 | OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES) Osteonics Corp. | LZO |
| Jun 9, 1989 | K891083 | CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER Depuy, Inc. | LZO |
| Jun 9, 1989 | K891082 | CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER Depuy, Inc. | LZO |
| May 10, 1989 | K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC Protek, Inc. | LZO |
| Mar 15, 1989 | K890060 | CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER Depuy, Inc. | LZO |
| Jun 17, 1986 | K861400 | THREADED TITANIUM METAL BACKED ACETABULAR CUP Depuy, Inc. | LZO |
| Apr 3, 1986 | K860275 | TI-FIT ACETABULAR COMPONENT Richards Medical Co., Inc. | LZO |
| Mar 5, 1985 | K844906 | THREADED TITANIUM METAL BACKED ACETABULAR CUP Depuy, Inc. | LZO |
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