Osteoimplant Technology, Inc.
Hunt Valley, MD, US
Osteoimplant Technology, Inc. appears in FDA device records in Hunt Valley, MD. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Osteoimplant Technology, Inc. between 1996 and 2005. The busiest year on record is 1998, with 4. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | LWJ | Substantially Equivalent | |
| K041443 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | LZO | Substantially Equivalent | |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | KWZ | Substantially Equivalent | |
| K032729 | Z-SERIES MODULAR TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K030608 | OTI BONE CEMENT PLUG | JDK | Unknown | |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | HSH | Substantially Equivalent | |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | HRY | Substantially Equivalent | |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM | LZO | Substantially Equivalent | |
| K003199 | TRIAD II MODULAR TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K984227 | OMEGA II MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K990003 | J-SERIES OMEGA TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K982886 | OTI MODULAR SHOULDER SYSTEM | HSD | Substantially Equivalent | |
| K982598 | OTI FEMORAL LOCK TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K980981 | OMEGA HA COATED TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K974506 | LSF HA COATED TRIAD TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K971020 | LSF TRIAD TOTAL HIP SYSTEM | LPH | Substantially Equivalent | |
| K964924 | OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) | LPH | Substantially Equivalent | |
| K960647 | OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS | JDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JDKProsthesis, Hip, Cement Restrictor
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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