Device 300419 Strip
510(k) K260364
Device 300419 Strip is a Class II device made by Geistlich Pharma AG, cleared under FDA 510(k) K260364 on 2 Jun 2026, 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 | NumberK260364 | Date2 Jun 2026 | StatusActive |
Official records
- FDA 510(k) database K260364
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- Withdrawn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).
- FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE by Prosidyan, Inc.
- AS20 COMPOSITE GRAFT by Wrightmedicaltechnologyinc
- APACERAM BONE GRAFT SUBSTITUTE by HOYA CORPORATION
- 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.