FDA Product Code
FDA Product Code JDL — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3320
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K073499 | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES | Zimmer, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K070785 | DYNASTY ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | 2007-07-11 | Special | PDF ↗ |
| K061844 | DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER | Wrightmedicaltechnologyinc | 2006-12-06 | Special | PDF ↗ |
| K051995 | PROFEMUR RENAISSANCE HIP STEM | Wrightmedicaltechnologyinc | 2005-08-22 | Special | PDF ↗ |
| K051348 | CONSERVE TOTAL FEMORAL HEAD | Wrightmedicaltechnologyinc | 2005-08-19 | Traditional | PDF ↗ |
| K042841 | M2A/C2A ACETABULAR SYSTEM | Biomet, Inc. | 2004-12-21 | Traditional | PDF ↗ |
| K041586 | PROFEMUR S HIP STEM | Wrightmedicaltechnologyinc | 2004-07-09 | Special | PDF ↗ |
| K041114 | PROFEMUR TAPERED HIP STEM | Wrightmedicaltechnologyinc | 2004-05-28 | Special | PDF ↗ |
| K004043 | METAL TRANSCEND ARTICULATION SYSTEM | Wrightmedicaltechnologyinc | 2001-07-13 | Abbreviated | PDF ↗ |
| K950542 | METAL BACKED ACETABULAR COMPONENT | Encore Orthopedics, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K944769 | P.F.C. APICAL PLUG | Johnson & Johnson Professionals, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K942809 | ACETABULAR DOME HOLE PLUGS | Osteonics Corp. | 1994-09-20 | Traditional | PDF ↗ |
| K931676 | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | Joint Medical Products Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K934440 | PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES | Howmedica Corp. | 1994-02-22 | Traditional | PDF ↗ |
| K930833 | PCA(R) SOLID BACK ACETABULA SHELL | Howmedica Corp. | 1994-02-22 | Traditional | PDF ↗ |
| K935669 | SYRIGENE PRE-FILLED SYRINGE | Regulatory & Marketing Services, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K922561 | CONSENSUS(TM) TOTAL HIP SYSTEM | U.S. Medical Products, Inc. | 1993-07-21 | Traditional | PDF ↗ |
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | Implantology Corp. | 1993-07-13 | Traditional | PDF ↗ |
| K915527 | CPS ACETABULAR COMPONENT | Implantology Corp. | 1993-06-24 | Traditional | PDF ↗ |
| K922861 | BIOMETRIC SCREW FIXATION CUP | Osteo Technology, Inc. | 1993-05-12 | Traditional | PDF ↗ |
| K920929 | POLY INSERT 20 DEGREE | Dow Corning Wright | 1993-05-05 | Traditional | PDF ↗ |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Techmedica, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K921139 | HEALEY REVISION COMPONENT SYSTEM | Biomet, Inc. | 1992-07-01 | Traditional | PDF ↗ |
| K921384 | PCA ACETABULAR INSERT II | Howmedica Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K920868 | ACETABULAR DOME AND SCREW HOLE PLUGS | Osteonics Corp. | 1992-05-26 | Traditional | PDF ↗ |
| K896614 | S.A.F. ACETABULAR CUP WITH POROUS COATING | Synergy Orthopaedics Intl., Inc. | 1990-01-09 | Traditional | PDF ↗ |
| K894965 | POROUS-COATED TITANIUM ACETABULAR CUP | Dow Corning Wright | 1989-11-17 | Traditional | PDF ↗ |
| K895607 | POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT | Exactech, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K892640 | PNEUMOTHORAX KIT, MOTIFICATION | Arrow Intl., Inc. | 1989-10-11 | Traditional | PDF ↗ |
| K870867 | KM-4(TM) METAL-BACKED ACETABULAR CUP | Kirschner Medical Corp. | 1987-05-08 | Traditional | PDF ↗ |
| K870234 | P.T.H. METAL-BACKED ACETABULAR CUP | Orthopaedic Device Corp. | 1987-03-20 | Traditional | PDF ↗ |
| K861264 | JOINT MEASUREMENT INDICATOR | Devcom, Inc. | 1986-04-15 | Traditional | PDF ↗ |
| K855042 | KM-3 ACETABULAR COMPONENT | Kirschner Medical Corp. | 1986-03-14 | Traditional | PDF ↗ |
| K854107 | DIMENSION TOTAL HIP PROSTHESIS POROUS COATED | Kirschner Medical Corp. | 1986-03-10 | Traditional | PDF ↗ |
| K854935 | LINK METAL-BACKED ACETABULAR CUPS | Link America, Inc. | 1986-03-05 | Traditional | PDF ↗ |
| K852369 | LIDGRER-LUND ACETABULAR SOCKETS | Link America, Inc. | 1985-06-18 | Traditional | PDF ↗ |
| K850793 | MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA | Intermedics Orthopedics | 1985-05-09 | Traditional | PDF ↗ |
| K850352 | MICRO-STRUC. ACETABULAR COMPON- MC2P | Osteonics Corp. | 1985-04-25 | Traditional | PDF ↗ |
| K844482 | MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT | Advanced Biosearch Assn. | 1985-02-19 | Traditional | PDF ↗ |
| K842893 | DORR HIP PROSTHESIS, ACETABULAR COMPON | Carbomedics, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K831792 | SELF-ALIGNING ACETABULAR COMPONENT | Endomedics, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K830662 | NATURAL LOCK ACETABULAR COMPONENT | Advanced Biosearch Assn. | 1983-04-11 | Traditional | PDF ↗ |
| K813599 | 101-32 FEMORAL COMPONENT | Intermedics Orthopedics | 1982-01-22 | Traditional | PDF ↗ |
| K790274 | BG PROXIMAL FEMUR | Howmedica Corp. | 1979-03-26 | Traditional | PDF ↗ |
| K770472 | PROSTHESIS, VIDAL TOTAL HIP | Howmedica Corp. | 1977-03-17 | Traditional | PDF ↗ |
Product code JDL · Class III · Orthopedic. Data: openFDA.