KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
FDA premarket approval N980003/S007 · decided 2009-02-13
Approval details
- PMA number
- N980003
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Djo Surgical
- Date received
- 2008-05-06
- Decision date
- 2009-02-13
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- APPROVAL FOR THE USE OF POLYETHYLENE REPLACEMENT ACETABULAR LINERS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| REVERSE SHOULDER PROSTHESIS (K092873) | Djo Surgical | 2009-10-27 |