NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
FDA premarket approval P970010 · decided 1998-12-23
Approval details
- PMA number
- P970010
- Trade name
- NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Synthes (Usa)
- Date received
- 1997-02-24
- Decision date
- 1998-12-23
- Days to decision
- 667 days
- Decision code
- APRL
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Paoli, PA
- Statement
- Indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures, in cases where early mobilization (cast for 2 weeks, then removable splint for 2-4 weeks) is indicated. Use of SRS alone in highly comminuted fractures is not indicated.
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510(k) clearances by this applicant
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| SYNTHES VA LCP ANKLE TRAUMA SYSTEM (K120854) | Synthes USA | 2012-06-18 |
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| 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 |