Skip to content

Osteopore Pcl Scaffold

by Osteopore, Inc.

510(k) K051093

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 NumberK051093 Date17 Mar 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0446-2012 FDA Unclassified (pre-2012) initiated 27 Apr 2011

    Product sterility may be compromised.

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  • Withdrawn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
GXP
Device Class
Class II
Regulation
21 CFR Part 882.5300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent