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 4 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051737 | MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE | Howmedica Osteonics Corp. | 2005-07-19 | Special | PDF ↗ |
| K051682 | EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM | Exactech, Inc. | 2005-07-19 | Special | PDF ↗ |
| K051588 | BIOLOX DELTA CERAMIC FEMORAL HEADS | Howmedica Osteonics Corp. | 2005-07-12 | Special | PDF ↗ |
| K051411 | ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS | Biomet, Inc. | 2005-06-29 | Special | PDF ↗ |
| K050556 | ALUMINA HEAD | Fournitures Hospitalieres Industrie | 2005-05-11 | Special | PDF ↗ |
| K043356 | WAGNER SL REVISION STEM LATERAL | Zimmer Austin, Inc. | 2005-04-18 | Special | PDF ↗ |
| K042091 | BIOLOX DELTA CERAMIC HEADS | Biomet, Inc. | 2005-03-25 | Traditional | PDF ↗ |
| K041940 | HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS | Howmedica Osteonics Corp. | 2005-02-11 | Traditional | PDF ↗ |
| K042992 | CORAIL AMT HIP PROSTHESIS | DePuy Orthopaedics, Inc. | 2005-02-11 | Traditional | PDF ↗ |
| K042035 | ALUMINA HEAD | Fournitures Hospitalieres Industrie | 2004-11-17 | Traditional | PDF ↗ |
| K041443 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | Osteoimplant Technology, Inc. | 2004-11-16 | Special | PDF ↗ |
| K042842 | NOVATION 12/14 PRESS-FIT FEMORAL STEM | Exactech, Inc. | 2004-11-09 | Special | PDF ↗ |
| K041170 | SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS | Howmedica Osteonics Corp. | 2004-11-09 | Traditional | PDF ↗ |
| K042249 | CLS SPOTORNO STEM | Zimmer Austin, Inc. | 2004-09-15 | Special | PDF ↗ |
| K040734 | MODIFICATION TO RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2004-08-25 | Traditional | PDF ↗ |
| K040803 | MS-30 FEMORAL STEM STANDARD AND LATERAL | Zimmer, Inc. | 2004-04-29 | Special | PDF ↗ |
| K040644 | MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD | DePuy Orthopaedics, Inc. | 2004-04-08 | Special | PDF ↗ |
| K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD | Stelkast Company | 2004-03-12 | Traditional | PDF ↗ |
| K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM | Centerpulse Orthopedics, Inc. | 2003-12-17 | Special | PDF ↗ |
| K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP | Centerpulse Orthopedics, Inc. | 2003-10-24 | Traditional | PDF ↗ |
| K032380 | WAGNER CONE PROSTHESIS | Centerpulse Orthopedics, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K031803 | DEPUY CERAMIC FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2003-07-01 | Special | PDF ↗ |
| K030724 | ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM | Zimmer, Inc. | 2003-06-03 | Traditional | PDF ↗ |
| K031217 | GMRS PRESS FIT STEMS WITH PUREFIX HA | Howmedica Osteonics | 2003-05-23 | Traditional | PDF ↗ |
| K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | Hayes Medical, Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | Centerpulse Orthopedics, Inc. | 2003-03-06 | Special | PDF ↗ |
| K023901 | ALUMINA V40 FEMORAL HEADS | Howmedica Osteonics Corp. | 2003-01-28 | Traditional | PDF ↗ |
| K022985 | ASCENDENT ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2002-12-05 | Traditional | PDF ↗ |
| K022403 | GMRS PRESS FIT STEMS WITH PUREFIX HA | Howmedica Osteonics Corp. | 2002-10-17 | Traditional | PDF ↗ |
| K022549 | RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2002-09-23 | Traditional | PDF ↗ |
| K022555 | ACCOLADE C FEMORAL STEMS | Howmedica Osteonics Corp. | 2002-08-26 | Special | PDF ↗ |
| K022120 | MPF ACETABULAR CUP GENERATION 2 | Plus Orthopedics | 2002-07-24 | Special | PDF ↗ |
| K021673 | TOTAL HIP FEMORAL HEAD - 12/14 TAPER | Smith & Nephew, Inc. | 2002-06-11 | Special | PDF ↗ |
| K020713 | MS-30 LATERAL FEMORAL STEM | Sulzer Orthopedics, Inc. | 2002-05-14 | Traditional | PDF ↗ |
| K013106 | 2 PIECE MODULAR HIP STEM | Howmedica Osteonics Corp. | 2002-04-03 | Traditional | PDF ↗ |
| K011533 | DEPUY FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K013989 | ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER | Smith & Nephew, Inc. | 2001-12-19 | Special | PDF ↗ |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | Sulzer Orthopedics, Inc. | 2001-12-13 | Special | PDF ↗ |
| K012918 | APEX MODULAR ALUMINA FEMORAL HEAD | Apex Surgical, LLC | 2001-11-27 | Traditional | PDF ↗ |
| K012091 | PRO-FEMUR | Wrightmedicaltechnologyinc | 2001-10-03 | Abbreviated | PDF ↗ |
| K011836 | MPF ACETABULAR CUP | Plus Orthopedics | 2001-09-07 | Traditional | PDF ↗ |
| K010839 | CLS VARUS STEM/CLS 135 STEM | Sulzer Orthopedics, Inc. | 2001-04-18 | Special | PDF ↗ |
| K003274 | LPC-PLUS ACETABULAR CUP | Plus Orthopedics | 2001-04-06 | Traditional | PDF ↗ |
| K003923 | APEX MODULAR ZIRCONIA FEMORAL HEAD | Apex Surgical, LLC | 2001-03-20 | Traditional | PDF ↗ |
| K010560 | PORTRAIT FEMORAL COMPONENT | Biomet, Inc. | 2001-03-20 | Special | PDF ↗ |
| K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM | Osteoimplant Technology, Inc. | 2001-01-19 | Traditional | PDF ↗ |
| K003379 | V-40/C-TAPER ADAPTER SLEEVE | Howmedica Osteonics Corp. | 2000-11-30 | Special | PDF ↗ |
| K003391 | OSTEONICS ALUMINA C-TAPER HEAD | Howmedica Osteonics Corp. | 2000-11-28 | Special | PDF ↗ |
| K003413 | ALUMINA V40 HEAD | Howmedica Osteonics Corp. | 2000-11-24 | Special | PDF ↗ |
| K002320 | ACCOLADE C FEMORAL COMPONENT | Howmedica Osteonics Corp. | 2000-09-14 | Traditional | PDF ↗ |
| K002441 | FENNING HIP STEM | DePuy Orthopaedics, Inc. | 2000-09-01 | Traditional | PDF ↗ |
| K001449 | TRIDENT ACETABULAR SHELLS: PS | Howmedica Osteonics Corp. | 2000-08-04 | Traditional | PDF ↗ |
| K993874 | BOFOR REVISION COUP | Plus Orthopedics | 2000-06-05 | Traditional | PDF ↗ |
| K000432 | RESPONSE 2000 CEMENTED HIP STEM | DePuy Orthopaedics, Inc. | 2000-04-24 | Traditional | PDF ↗ |
| K000392 | RESPONSE 2000 HIP STEM | DePuy Orthopaedics, Inc. | 2000-04-24 | Traditional | PDF ↗ |
| K992359 | MRS-TITAN | Rotec Medizintechnik GmbH | 2000-02-18 | Traditional | PDF ↗ |
| K994184 | PLR SPLINED REVISION STEM | Biomet, Inc. | 2000-02-15 | Traditional | PDF ↗ |
| K993889 | EXETER CERAMIC FEMORAL HEADS | Howmedica Osteonics Corp. | 2000-02-11 | Traditional | PDF ↗ |
| K991162 | BIOLOX ALUMINA CERAMIC FEMORAL HEAD | Smith & Nephew, Inc. | 2000-01-28 | Abbreviated | PDF ↗ |
| K992403 | MRP-TITAN | Rotec Medizintechnik GmbH | 2000-01-21 | Traditional | PDF ↗ |
| K993043 | MS-30 FEMORAL STEM | Sulzer Orthopedics, Inc. | 1999-12-02 | Traditional | PDF ↗ |
| K992235 | ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS | Corin USA | 1999-11-23 | Traditional | PDF ↗ |
| K992144 | BIOPRO RIMMED ACETABULAR COMPOMENT | Biologically Oriented Prostheses | 1999-09-22 | Traditional | PDF ↗ |
| K990261 | PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) | Plus Orthopedics | 1999-08-27 | Traditional | PDF ↗ |
| K991708 | ZIRCONIA 22.22MM CERAMIC MODULAR HEADS | Biomet, Inc. | 1999-07-30 | Abbreviated | PDF ↗ |
| K991952 | OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS | Howmedica Osteonics Corp. | 1999-06-29 | Special | PDF ↗ |
| K990183 | IMPLEX ALUMINA FEMORAL HEAD | Implex Corp. | 1999-06-11 | Traditional | PDF ↗ |
| K991226 | FOUNDATION POROUS HIP STEM | Encore Orthopedics, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Howmedica Corp. | 1998-12-22 | Traditional | PDF ↗ |
| K981847 | BIOLOX ALUMINA CERAMIC FEMORAL HEAD | Smith & Nephew, Inc. | 1998-07-17 | Abbreviated | PDF ↗ |
| K981302 | SMC 28MM CERAMIC FEMORAL HEADS | Signal Medical Corp. | 1998-06-25 | Traditional | PDF ↗ |
| K981201 | OSTEOLOCK ACETABULAR CUP | Howmedica Corp. | 1998-05-29 | Traditional | PDF ↗ |
| K980774 | OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS | Osteonics Corp. | 1998-04-29 | Traditional | PDF ↗ |
| K980473 | PRESS-FIT STEM | Encore Orthopedics, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K980239 | PARTNERSHIP CALCAR FEMORAL COMPONENTS | Howmedica, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K980081 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | Johnson & Johnson Professionals, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K973837 | CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL | Sulzer Orthopedics, Inc. | 1998-01-06 | Traditional | PDF ↗ |
| K973681 | NATURAL-HIP COCR OFFSET STEM | Sulzer Orthopedics, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K972228 | MERIDIAN TITANIUM FEMORAL STEMS | Howmedica, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K973307 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | Johnson & Johnson Professionals, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K973087 | MOST HEX INTRAMEDULLARY (I/M) STEM | Sulzer Orthopedics, Inc. | 1997-11-14 | Traditional | PDF ↗ |
| K972893 | PARTNERSHIP REVISION FEMORAL STEMS | Howmedica Corp. | 1997-11-03 | Traditional | PDF ↗ |
| K972690 | ZIRCONIA CERAMIC FEMORAL HEAD | Zimmer, Inc. | 1997-10-15 | Traditional | PDF ↗ |
| K972637 | PRECEDENT REVISION HIP SYSTEM | Sulzer Orthopedics, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K972361 | V40 ZIRCONIA FEMORAL HEADS | Howmedica, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K970675 | HEADLOC CERAMIC HEAD | Ortho Development Corp. | 1997-08-22 | Traditional | PDF ↗ |
| K964431 | ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) | Biomet, Inc. | 1997-08-11 | Traditional | PDF ↗ |
| K971752 | ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) | Zimmer, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K971414 | ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS | Smith & Nephew, Inc., Orthopaedic Div. | 1997-07-16 | Traditional | PDF ↗ |
| K971497 | OSTEONICS ANTEVERTED NECK HIP STEM | Osteonics Corp. | 1997-07-16 | Traditional | PDF ↗ |
| K971409 | OSTEONICS ALUMINA C-TAPER HEAD | Osteonics Corp. | 1997-07-09 | Traditional | PDF ↗ |
| K971426 | HEADLOC CERAMIC HEAD | Ortho Development Corp. | 1997-07-09 | Traditional | PDF ↗ |
| K971435 | HEADLOC CERAMIC FEMORAL HEADS | Ortho Development Corp. | 1997-07-09 | Traditional | PDF ↗ |
| K965002 | ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND | Encore Orthopedics, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K970846 | 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD | Landos, Inc. | 1997-06-05 | Traditional | PDF ↗ |
| K970490 | PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT | Stelkast Company | 1997-05-02 | Traditional | PDF ↗ |
| K970200 | RELIANCE PF FEMORAL STEMS | Howmedica Corp. | 1997-04-09 | Traditional | PDF ↗ |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | Intermedics Orthopedics | 1997-04-08 | Traditional | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.