COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
FDA 510(k) clearance K000122 · decided 2001-09-20
Clearance details
- K-number
- K000122
- Device name
- COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
- Applicant
- Neucoll, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-18
- Decision date
- 2001-09-20
- Days to decision
- 611 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S015) | Neucoll, Inc. | 2005-01-24 |
| NEUGRAFT (P900039/S013) | Neucoll, Inc. | 2004-06-07 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S012) | Neucoll, Inc. | 2002-10-10 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S011) | Neucoll, Inc. | 2002-07-02 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S010) | Neucoll, Inc. | 1998-12-07 |
| COLLAGRAFT BONE GRAFT MATRIX (P900039/S009) | Neucoll, Inc. | 1996-02-01 |
| COLLAGRAFT(TM) BONE GRAFT MATRIX (P900039/S008) | Neucoll, Inc. | 1995-10-30 |
| COLLAGRAFT(TM) BONE GRAFT MATRIX (P900039/S006) | Neucoll, Inc. | 1995-03-21 |