COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
FDA premarket approval P900039/S002 · decided 1993-08-05
Approval details
- PMA number
- P900039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 1993-07-02
- Decision date
- 1993-08-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
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 |
|---|---|---|
| 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 |