APR METASUL ACETABULAR INSERT
FDA 510(k) clearance K993569 · decided 1999-12-01
Clearance details
- K-number
- K993569
- Device name
- APR METASUL ACETABULAR INSERT
- Applicant
- Sulzermedica
- Decision
- Substantially Equivalent
- Date received
- 1999-10-21
- Decision date
- 1999-12-01
- Days to decision
- 41 days
- Clearance type
- Special
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
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| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NATURAL-KNEE AND NATURAL-KNEE II (P940002/S005) | Sulzermedica | 2001-08-01 |
| NATURAL KNEE & NATURAL KNEE II (P940002/S003) | Sulzermedica | 2000-04-18 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S002) | Sulzermedica | 1997-10-16 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S001) | Sulzermedica | 1997-04-30 |
| NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) (P940002) | Sulzermedica | 1997-03-21 |