Osteo Technology, Inc.
Timonium, MD, US
Osteo Technology, Inc. appears in FDA device records in Timonium, MD. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Osteo Technology, Inc. between 1992 and 1994. The busiest year on record is 1993, with 16. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 16 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | LPH | Substantially Equivalent for Some Indications | |
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | JWH | Substantially Equivalent | |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | JWH | Substantially Equivalent | |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | JDQ | Substantially Equivalent | |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K922861 | BIOMETRIC SCREW FIXATION CUP | JDL | Substantially Equivalent | |
| K922870 | THREE SPIKE CUP | GRF | Substantially Equivalent | |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | HTY | Substantially Equivalent | |
| K922682 | AMERICANA HIP PROTHESIS | JDG | Substantially Equivalent | |
| K922871 | UNIFIT FEMORAL STEM | JDI | Substantially Equivalent | |
| K922868 | THOMPSON TYPE HIP PROTHESIS | KWA | Substantially Equivalent | |
| K922866 | OTI BONE PLUG | JDI | Substantially Equivalent | |
| K922864 | MUELLER TYPE FEMORAL STEM | JDI | Substantially Equivalent | |
| K922863 | EUROSTEM HIP PROTHESIS SYSTEM | JDI | Substantially Equivalent | |
| K922862 | CHARNLEY TYPE HIP PROTHESIS | JDI | Substantially Equivalent | |
| K922860 | AUSTIN-MOORE TYPE HIP PROSTHESIS | JDI | Substantially Equivalent | |
| K922645 | LSF ANATOMIC CEMENTED HIP | JDI | Substantially Equivalent | |
| K922865 | NEER TYPE SHOULDER PROSTHESIS SYSTEM | KWT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GRFAntiserum, Cf, Rubeola
- JDQCerclage, Fixation
- HTYPin, Fixation, Smooth
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- HSBRod, Fixation, Intramedullary And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain