NORIAN SRS CEMENT
FDA premarket approval P970010/S001 · decided 1999-07-16
Approval details
- PMA number
- P970010
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- NORIAN SRS CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Synthes (Usa)
- Date received
- 1999-02-08
- Decision date
- 1999-07-16
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Paoli, PA
- Statement
- Approval for the post-approval clinical and animal study protocols that were requested as Conditions of Approval for the PMA.
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 |
|---|---|---|
| DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM (K141527) | Synthes USA | 2015-03-30 |
| SYNTHES SYNSONIC ULNA NAIL (K131984) | Synthes (Usa) | 2014-03-31 |
| SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE (K121601) | Synthes USA | 2012-07-06 |
| SYNTHES VA LCP ANKLE TRAUMA SYSTEM (K120854) | Synthes USA | 2012-06-18 |
| SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) (K120717) | Synthes USA | 2012-05-08 |
| SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070) | Synthes USA | 2012-03-21 |
| SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) (K120083) | Synthes USA | 2012-02-08 |
| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |