Company ยท US
Osteo Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1994. Name variants (Inc, Corp, punctuation) are merged.
18510(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 | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| GRF | Antiserum, Cf, Rubeola | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 |
| JDQ | Cerclage, Fixation | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 1994 | K926156 | REPLICA(TM) TOTAL HIP SYSTEM Osteo Technology, Inc. | LPH |
| Sep 23, 1993 | K922859 | ANATOMICAL TYPE KNEE SYSTEM Osteo Technology, Inc. | JWH |
| Jul 13, 1993 | K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM Osteo Technology, Inc. | JWH |
| Jun 29, 1993 | K925447 | OTI ORTHOPEDIC WIRE SYSTEM Osteo Technology, Inc. | JDQ |
| Jun 17, 1993 | K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM Osteo Technology, Inc. | HSB |
| May 12, 1993 | K922861 | BIOMETRIC SCREW FIXATION CUP Osteo Technology, Inc. | JDL |
| Apr 8, 1993 | K922870 | THREE SPIKE CUP Osteo Technology, Inc. | GRF |
| Mar 16, 1993 | K925301 | OTI ORTHOPEDIC FASTENER SYSTEM Osteo Technology, Inc. | HTY |
| Mar 16, 1993 | K922682 | AMERICANA HIP PROTHESIS Osteo Technology, Inc. | JDG |
| Feb 12, 1993 | K922871 | UNIFIT FEMORAL STEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922868 | THOMPSON TYPE HIP PROTHESIS Osteo Technology, Inc. | KWA |
| Feb 12, 1993 | K922866 | OTI BONE PLUG Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922864 | MUELLER TYPE FEMORAL STEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922863 | EUROSTEM HIP PROTHESIS SYSTEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922862 | CHARNLEY TYPE HIP PROTHESIS Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922860 | AUSTIN-MOORE TYPE HIP PROSTHESIS Osteo Technology, Inc. | JDI |
| Jan 7, 1993 | K922645 | LSF ANATOMIC CEMENTED HIP Osteo Technology, Inc. | JDI |
| Dec 10, 1992 | K922865 | NEER TYPE SHOULDER PROSTHESIS SYSTEM Osteo Technology, Inc. | KWT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||