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Temperlite(Tm) Saw Blade

by Sierra Surgical, Inc.

510(k) K911902

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 NumberK911902 Date28 Jun 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1127-2013 FDA Class II initiated 14 Mar 2013

    Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

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  • Withdrawn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
HSD
Device Class
Class II
Regulation
21 CFR Part 888.3690
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent