STELKAST SURPASS ACETABULAR SYSTEM
FDA premarket approval P040051/S002 · decided 2011-04-22
Approval details
- PMA number
- P040051
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- STELKAST SURPASS ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Stelkast Company
- Date received
- 2009-10-06
- Decision date
- 2011-04-22
- Days to decision
- 563 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mcmurray, PA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM (K122883) | Stelkast Company | 2013-08-05 |
| CROSS-OVER ACETABULAR SHELL & LINER (K122773) | Stelkast Company | 2012-10-09 |
| EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (K094035) | Stelkast Company | 2011-03-24 |
| PROVEN STEM EXTENDER (K081458) | Stelkast Company | 2008-06-06 |
| PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (K063211) | Stelkast Company | 2007-01-18 |
| PROVEN REVISION MODULAR TIBIAL TRAY (K051976) | Stelkast Company | 2005-10-17 |
| STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (K033944) | Stelkast Company | 2004-03-12 |
| STELKAST UNICONDYLAR KNEE SYSTEM (K032824) | Stelkast Company | 2003-11-13 |