COLLAGRAFT STRIP BONE GRAFT MATRIX
FDA premarket approval P900039/S012 · decided 2002-10-10
Approval details
- PMA number
- P900039
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAGRAFT STRIP BONE GRAFT MATRIX
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 2002-09-12
- Decision date
- 2002-10-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
- Statement
- CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER). ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) (K000122) | Neucoll, Inc. | 2001-09-20 |