Company ยท US
Osteonics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2000. Name variants (Inc, Corp, punctuation) are merged.
178510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 29 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 24 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 24 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 |
| HWC | Screw, Fixation, Bone | 8 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 8 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 |
| HRS | Plate, Fixation, Bone | 6 |
| JDK | Prosthesis, Hip, Cement Restrictor | 6 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 6 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 5 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 3 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 3 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2000 | K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY Osteonics Corp. | HRY |
| Jul 23, 1999 | K980070 | OSTEONICS HA-COATED DEVICES Osteonics Corp. | MEH |
| Apr 30, 1999 | K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY Osteonics Corp. | KWP |
| Mar 25, 1999 | K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM Osteonics Corp. | KWQ |
| Feb 24, 1999 | K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE Osteonics Corp. | KWL |
| Feb 18, 1999 | K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp. | MEH |
| Feb 1, 1999 | K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER Osteonics Corp. | MNI |
| Dec 18, 1998 | K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS Osteonics Corp. | MNH |
| Dec 16, 1998 | K984353 | OSTEO 9MM IC TIBIAL NAIL Osteonics Corp. | HSB |
| Dec 16, 1998 | K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. | LPH |
| Dec 11, 1998 | K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM Osteonics Corp. | MEH |
| Dec 7, 1998 | K983508 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM Osteonics Corp. | HWC |
| Dec 4, 1998 | K983226 | OSTEONICS X CEMENTED HIP STEM SERIES Osteonics Corp. | JDI |
| Dec 3, 1998 | K983165 | OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| Dec 2, 1998 | K983870 | OSTEONICS RESTORATION HA HIP STEMS Osteonics Corp. | MEH |
| Oct 27, 1998 | K983339 | OSTEO DYNATROC PROXIMAL FEMORAL NAIL Osteonics Corp. | HSB |
| Oct 21, 1998 | K982936 | OSTEONICS EXTENDED FEMORAL BEARING HEAD Osteonics Corp. | LWJ |
| Sep 25, 1998 | K983152 | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS Osteonics Corp. | MNH |
| Sep 22, 1998 | K982553 | OSTEO COMPRESSION HIP SCREW SYSTEM Osteonics Corp. | HRS |
| Sep 22, 1998 | K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS Osteonics Corp. | JDI |
| Sep 14, 1998 | K982601 | OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL Osteonics Corp. | HSB |
| Jul 9, 1998 | K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp. | MEH |
| Jun 22, 1998 | K981309 | OSTEO I-C HUMERAL NAIL SYSTEM Osteonics Corp. | HSB |
| May 27, 1998 | K980766 | OSTEONICS ANTEVERTED NECK HA HIP STEMS Osteonics Corp. | MEH |
| May 20, 1998 | K981452 | OSTEONICS LONG ARM CONTAINMENT RING Osteonics Corp. | KWP |
| May 11, 1998 | K981259 | OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| May 5, 1998 | K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS Osteonics Corp. | LYT |
| May 5, 1998 | K980502 | OSTEONICS TOTAL ELBOW SYSTEM Osteonics Corp. | JDC |
| Apr 29, 1998 | K980774 | OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS Osteonics Corp. | LZO |
| Mar 16, 1998 | K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM Osteonics Corp. | KWL |
| Feb 27, 1998 | K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM Osteonics Corp. | JWH |
| Jan 16, 1998 | K972967 | OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT Osteonics Corp. | JWH |
| Jan 12, 1998 | K974434 | OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS Osteonics Corp. | HRY |
| Dec 9, 1997 | K973438 | OSTEO BOS SYSTEM PRODUCT LINE EXTENSION Osteonics Corp. | HRS |
| Dec 8, 1997 | K973406 | OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT Osteonics Corp. | JWH |
| Sep 25, 1997 | K973204 | OSTEO BOS SYSTEM IN STAINLESS STEEL Osteonics Corp. | HRS |
| Sep 25, 1997 | K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) Osteonics Corp. | JDI |
| Sep 10, 1997 | K972323 | OSTEO BOS SYSTEM Osteonics Corp. | HRS |
| Aug 25, 1997 | K972196 | OSTEO ANATOMICAL BONE PLATES Osteonics Corp. | HRS |
| Aug 11, 1997 | K971962 | OSTEO KIRSCHNER WIRES Osteonics Corp. | HTY |
| Jul 30, 1997 | K971800 | OSTEO CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| Jul 16, 1997 | K971497 | OSTEONICS ANTEVERTED NECK HIP STEM Osteonics Corp. | LZO |
| Jul 9, 1997 | K971654 | OSTEO COMPRESSION HIP SCREW SYSTEM Osteonics Corp. | HWC |
| Jul 9, 1997 | K971409 | OSTEONICS ALUMINA C-TAPER HEAD Osteonics Corp. | LZO |
| Jul 9, 1997 | K971321 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM Osteonics Corp. | HRS |
| Jun 27, 1997 | K971778 | OSTEO SMALL AND MINI BONE SCREWS Osteonics Corp. | HWC |
| Jun 3, 1997 | K970957 | OSTEONICS RESTORATION ACETABULAR RING Osteonics Corp. | JDJ |
| May 22, 1997 | K971422 | OSTEONICS ACETABULAR WEDGE SYSTEM Osteonics Corp. | MEH |
| May 9, 1997 | K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS Osteonics Corp. | LZN |
| Apr 24, 1997 | K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM Osteonics Corp. | JDI |
Newest 50 of 178.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||