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POLYGRAFT BGS - Bone Graft Substitute

by Osteobiologics, Inc. 2 variants

510(k) K040047

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040047 Date17 Dec 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0440-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006

    Mis-packaging-product in the package may be a different size than indicated on the labeling.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQV
Models / Variants
Bone Graft Substitute
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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