FDA Product Code
FDA Product Code LZO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3353
510(k) Clearances — 535 records · page 6 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K914676 | ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER | Zimmer, Inc. | 1992-01-13 | Traditional | PDF ↗ |
| K912985 | LIMA 28MM CERAMIC HEAD, MODIFICATION | Turnkey Intergration USA, Inc. | 1991-12-24 | Traditional | PDF ↗ |
| K914237 | KINAMED CTN STEM | Kinamed, Inc. | 1991-12-05 | Traditional | PDF ↗ |
| K912641 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS | Biopro, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913633 | TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS | Intermedics Orthopedics | 1991-11-22 | Traditional | PDF ↗ |
| K912295 | KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL | Kinamed, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K905687 | ZIRCONIA CERAMIC MODULAR HEADS | Biomet, Inc. | 1991-04-15 | Traditional | PDF ↗ |
| K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | Turnkey Intergration USA, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) | Turnkey Intergration USA, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K905739 | ZIMMER CERAMIC FEMORAL HEADS | Zimmer, Inc. | 1991-03-07 | Traditional | PDF ↗ |
| K905260 | TOTAL HIP FEMORAL COMPONENT | Intermedics Orthopedics | 1991-01-30 | Traditional | PDF ↗ |
| K904028 | DCW MODULAR PROXIMAL FEMORAL SYSTEM | Dow Corning Wright | 1991-01-14 | Traditional | PDF ↗ |
| K903976 | CTH STABILO TOTAL HIP REPLACEMENT SYSTEM | Kinamed, Inc. | 1991-01-09 | Traditional | PDF ↗ |
| K902712 | OSTEONICS PS HEAD AND NECK HIP STEM SERIES | Osteonics Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K902073 | KINAMED CEMENTED ATH-LONG STEM | Kinamed, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K902074 | KINAMED CEMENTED CTH STEM | Kinamed, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K896850 | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE | Lima Intl. Corp. | 1990-06-05 | Traditional | PDF ↗ |
| K900628 | MODULAR HIP SYSTEM | Richards Medical Co., Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K894904 | KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL | Kinamed, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K896669 | WEBER PERMALOCK | Allo Pro Corp. | 1990-02-06 | Traditional | PDF ↗ |
| K895399 | KIM MODULAR FEMORAL HIP PROSTHESIS | Dow Corning Wright | 1989-12-14 | Traditional | PDF ↗ |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | Richards Medical Co., Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K892644 | BIOLOX CERAMIC BALL | Allo Pro Corp. | 1989-10-19 | Traditional | PDF ↗ |
| K894694 | OMNIFIT CERAMIC MORSE TAPER HEAD | Osteonics Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K893685 | CERAMIC FEMORAL HEAD | Dow Corning Wright | 1989-09-26 | Traditional | PDF ↗ |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | Richards Medical Co., Inc. | 1989-09-01 | Traditional | PDF ↗ |
| K890472 | ATH CERAMIC UHMWPE TOTAL HIP SYSTEM | Kinamed, Inc. | 1989-09-01 | Traditional | PDF ↗ |
| K885102 | OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES) | Osteonics Corp. | 1989-06-22 | Traditional | PDF ↗ |
| K891082 | CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER | Depuy, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K891083 | CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER | Depuy, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC | Protek, Inc. | 1989-05-10 | Traditional | PDF ↗ |
| K890060 | CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER | Depuy, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K861400 | THREADED TITANIUM METAL BACKED ACETABULAR CUP | Depuy, Inc. | 1986-06-17 | Traditional | PDF ↗ |
| K860275 | TI-FIT ACETABULAR COMPONENT | Richards Medical Co., Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K844906 | THREADED TITANIUM METAL BACKED ACETABULAR CUP | Depuy, Inc. | 1985-03-05 | Traditional | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.