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 5 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970346 | PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT | Kairos Orthopaedics | 1997-02-19 | Traditional | PDF ↗ |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | Intermedics Orthopedics | 1997-01-27 | Traditional | PDF ↗ |
| K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT | Hayes Medical, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K964704 | DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM | Depuy, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K964249 | BRIDGE LONG STEM FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 1997-01-14 | Traditional | PDF ↗ |
| K953111 | CORAIL | Landos, Inc. | 1996-12-27 | Traditional | PDF ↗ |
| K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1996-12-27 | Traditional | PDF ↗ |
| K955877 | ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD | Zimmer, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K962248 | P.F.C. CERAMIC HIP HEAD | Johnson & Johnson Professionals, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K962101 | ZWEYMUELLER SL FEMORAL HIP STEM | Intermedics Orthopedics | 1996-08-19 | Traditional | PDF ↗ |
| K960588 | WAGNER REVISION STEM | Intermedics Orthopedics | 1996-08-05 | Traditional | PDF ↗ |
| K961921 | APR OVERSIZED HIP STEM | Intermedics Orthopedics | 1996-08-05 | Traditional | PDF ↗ |
| K961727 | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM | Intermedics Orthopedics | 1996-07-19 | Traditional | PDF ↗ |
| K961589 | APR FULLY TEXTURED HIP STEM | Intermedics Orthopedics | 1996-07-09 | Traditional | PDF ↗ |
| K953690 | CLS STEM (MODIFICATION) | Intermedics Orthopedics | 1996-06-07 | Traditional | PDF ↗ |
| K955117 | IMPLEX CERAMIC HEAD | Implex Corp. | 1996-04-05 | Traditional | PDF ↗ |
| K955386 | CONSENSUS ZIRCONIA FEMORAL HEAD | U.S. Medical Products, Inc. | 1996-02-20 | Traditional | PDF ↗ |
| K955350 | BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM | Biomet, Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K953925 | FINE GRAIN CAST COBALT CHROMIUM HIP STEMS | Biomet, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K954768 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD | Biologically Oriented Prostheses | 1996-01-18 | Traditional | PDF ↗ |
| K953688 | CLS ACETABULAR COMPONENT (MODIFICATION) | Intermedics Orthopedics | 1995-11-29 | Traditional | PDF ↗ |
| K953689 | WAGNER REVISION STEM (MODIFICATION) | Intermedics Orthopedics | 1995-11-29 | Traditional | PDF ↗ |
| K953792 | CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 | U.S. Medical Products, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K944689 | ZIRCONIA CERAMIC FEMORAL HEAD | Wrightmedicaltechnologyinc | 1995-10-20 | Traditional | PDF ↗ |
| K953045 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD | Biologically Oriented Prostheses | 1995-09-27 | Traditional | PDF ↗ |
| K952686 | BUCHALTER FAUSER FEMORAL COMPONENTS | Biomet, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K953169 | STELKAST ALL POLYETHYLENE ACETABULAR CUP | Stelkast Company | 1995-08-08 | Traditional | PDF ↗ |
| K952418 | V40 ZIRCONIA FEMORAL HEADS | Howmedica Corp. | 1995-07-03 | Traditional | PDF ↗ |
| K952088 | ZIRCONIA ARTICUL/EZE FEMORAL BALLS | Depuy, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K946026 | HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS | Howmedica, Inc. | 1995-03-20 | Traditional | PDF ↗ |
| K943774 | OSTEONICS RESTORATION MONOLITHIC HIP STEM | Osteonics Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K945516 | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM | Intermedics Orthopedics | 1995-02-14 | Traditional | PDF ↗ |
| K945089 | SENTRY TOTAL HIP | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945090 | HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945092 | P.C.A.PRIMARY HIP- CEMENTLESS USE | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945096 | CDH HIP STEM | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945093 | P.C.A. E-SERIES HIP- CEMENTLESS USE | Howmedica, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K945095 | APC FEMORAL COMPONENT | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945094 | HNR-PC HIP | Howmedica Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K945091 | HOWMEDICA ALUMINA FEMORAL HEAD | Howmedica Corp. | 1995-01-18 | Traditional | PDF ↗ |
| K944601 | ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD | Zimmer, Inc. | 1995-01-12 | Traditional | PDF ↗ |
| K935913 | HOWMEDICA SENTRY S TOTAL HIP SYSTEM | Howmedica, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K944209 | APR II NON POROUS HIP STEM | Intermedics Orthopedics | 1994-12-09 | Traditional | PDF ↗ |
| K935921 | ZIRCONIA CERAMIC FEMORAL HEAD | Smith & Nephew Richards, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K936256 | MODULAR CERAMIC FEMORAL HEAD | Stelkast Company | 1994-11-14 | Traditional | PDF ↗ |
| K943586 | ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) | Biomet, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K933942 | SOLUTION BOWED FEMORAL HIP PROTSTHESIS | Depuy, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | Johnson & Johnson Orthopaedics, Inc. | 1994-10-06 | Traditional | PDF ↗ |
| K942330 | APR II FEMORAL COMPONENT (VARIOUS) | Intermedics Orthopedics | 1994-10-04 | Traditional | PDF ↗ |
| K933275 | P.F.C. CERAMIC HIP HEAD | Johnson & Johnson Orthopaedics, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K933108 | TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS | Landos, Inc. | 1994-09-12 | Traditional | PDF ↗ |
| K935193 | CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM | U.S. Medical Products, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K941847 | 5/8 POROCOAT AML HIP POROCOAT POROUS COATING | Depuy, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K941942 | SOLUTION HIP | Depuy, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K934457 | STABILITY HIP STEM WITH POROCOAT | Depuy, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K935185 | MORPHOMETRIC TOTAL HIP PROSTHESIS | Landos, Inc. | 1994-06-16 | Traditional | PDF ↗ |
| K932935 | TITAN DYSPLASIC TOTAL HIP PROSTHESIS | Landos, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K931617 | EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT | Exactech, Inc. | 1994-06-14 | Traditional | PDF ↗ |
| K932222 | SLT FEMORAL HEAD | Dow Corning Wright | 1994-05-27 | Traditional | PDF ↗ |
| K934694 | KIRSCHNER ZIRCONIA FEMORAL HEAD | Kirschner Medical Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K933499 | CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM | U.S. Medical Products, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K933567 | EUROFORM TOTAL HIP PROSTHESIS | Landos, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | Link America, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K933203 | APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP | Intermedics Orthopedics | 1994-04-19 | Traditional | PDF ↗ |
| K922247 | KINAMED REALITY TOTAL HIP SYSTEM | Kinamed, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | Techmedica, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K931572 | LINK CERAMIC HEADS 14/16 X 32MM | Link America, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K932519 | OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM | Osteonics Corp. | 1994-03-10 | Traditional | PDF ↗ |
| K926395 | ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM | Depuy, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K925345 | ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) | Biomet, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K930788 | ZIRCONIA CERAMIC FEMORAL HEAD | Smith & Nephew Richards, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K921224 | BIMETRIC TOTAL HIP SYSTEM | Biomet, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K921181 | MALLORY-HEAD TOTAL HIP SYSTEM | Biomet, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K921225 | INTEGRAL TOTAL HIP SYSTEM | Biomet, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | Johnson & Johnson Orthopaedics, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K930963 | SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS | Encore Orthopedics, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K925682 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED | Biopro, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR | Johnson & Johnson Orthopaedics, Inc. | 1993-10-04 | Traditional | PDF ↗ |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Techmedica, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K915222 | WALKER HIP PROSTHESIS | Zimmer, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K923734 | TOTAL HIP PROTHESIS FEMORAL COMPONENT | Intermedics Orthopedics | 1993-06-14 | Traditional | PDF ↗ |
| K920968 | INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD | Dow Corning Wright | 1993-05-05 | Traditional | PDF ↗ |
| K925695 | OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD | Osteonics Corp. | 1993-04-20 | Traditional | PDF ↗ |
| K925512 | CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION | Dow Corning Wright | 1993-02-12 | Traditional | PDF ↗ |
| K923583 | ORTHOMET PERFECTA TOTAL HIP SYSTEM | Orthomet, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K921836 | PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD | Orthomet, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K915641 | ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER | Biomet, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K920290 | KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL | Kinamed, Inc. | 1992-11-03 | Traditional | PDF ↗ |
| K920219 | KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL | Kinamed, Inc. | 1992-10-30 | Traditional | PDF ↗ |
| K921111 | S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD | Joint Medical Products Corp. | 1992-10-22 | Traditional | PDF ↗ |
| K915396 | OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD | Osteonics Corp. | 1992-10-20 | Traditional | PDF ↗ |
| K920145 | BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM | Biopro, Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K920593 | CERAMIC FEMORAL HEAD | Dow Corning Wright | 1992-08-31 | Traditional | PDF ↗ |
| K920756 | FELDMUHLE CERAMIC HEAD | Link America, Inc. | 1992-05-18 | Traditional | PDF ↗ |
| K920577 | HOWEDICA ZIRCONIA FEMORAL HEAD | Howmedica Corp. | 1992-05-15 | Traditional | PDF ↗ |
| K915310 | KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL | Kinamed, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K915309 | KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL | Kinamed, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K915184 | HOWMEDICA ALUMINA FEMORAL HEAD | Pfizer Hospital Products Group, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K913420 | ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF | Biomet, Inc. | 1992-01-16 | Traditional | PDF ↗ |
| K914574 | EXACTECH CERAMIC FEMORAL HEAD COMPONENT | Exactech, Inc. | 1992-01-13 | Traditional | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.