OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
FDA 510(k) clearance K040225 · decided 2004-05-06
Clearance details
- K-number
- K040225
- Device name
- OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
- Applicant
- Osteoimplant Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-02
- Decision date
- 2004-05-06
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- KWZ
- Device class
- 2
- Regulation number
- 888.3310
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hunt Valley, MD, US
- Third-party review
- No
- Expedited review
- No
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| TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (K072121) | Zimmer, Inc. | 2008-01-07 |
| DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059) | DePuy Orthopaedics, Inc. | 2007-11-09 |
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Recalls involving this device
No recalls on record reference this clearance.