Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation

510(k) K100986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

11 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK100986	Date20 Jul 2010Cleared	StatusActive

11 recalls · FDA

9 recalls, same reason
- Terminated Z-2595-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2624-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2596-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2612-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2613-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2625-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2608-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2609-2020 FDA Class II initiated 6 Apr 2020
- Terminated Z-2626-2020 FDA Class II initiated 6 Apr 2020
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
2 recalls, same reason
- Terminated Z-2186-2020 FDA Class II initiated 2 Apr 2020
- Terminated Z-2185-2020 FDA Class II initiated 2 Apr 2020
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

1 jurisdiction

United States — FDA 510(k) Active

510(k)