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Primalok Facet Fixation System

by Osteomed LP

510(k) K102438

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 NumberK102438 Date30 Sep 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0008-2012 FDA Unclassified (pre-2012) initiated 7 Jun 2011

    Two of the Implant Driver Assembly tips were reported to break during surgery.

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  • Withdrawn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
MRW
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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