Exactech Resorbable Bone Paste
510(k) K020078
Exactech Resorbable Bone Paste is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K020078 on 27 Feb 2004, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020078 | Date27 Feb 2004 | StatusActive |
Official records
- FDA 510(k) database K020078
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
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- A-GRIX TE RESORABLE BONE VOID FILLER by Ag Digital Technology Corp.
- MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT by MEDTRONIC SOFAMOR DANEK, INC.
- KENSEY NASH BONE VOID FILLER by Kensey Nash Corp.
- FM-02 BONE GRAFT SUBSTITUTE by Orthovita, Inc.
- GlassBone Granules by Noraker
- CaP Spheres Pellet Pack by Zimmer Biomet Spine, Inc.
- Tactoset Injectable Bone Substitute by Anika Therapeutics, Inc.
- HydroSet XT by Orthovita, Inc.
- KASIOS TCP by Kasios Biomaterials