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Biosorb Resorbable Void Filler

by Sciences ET Bio Materiaux (Sbm) 510(k)

Active United States Open recall

510(k) K021963

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021963 Date28 Jan 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1718-2025 FDA Class II initiated 7 Apr 2025

    Vials of implant bone granules may contain less product then specified on labeling.

Specification

510(k)

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

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