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Smith & Nephew Hip Arthroscopy Repair Instrument Tray

by Smith & Nephew Inc., Endoscopy Div.

510(k) K102544

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 NumberK102544 Date5 Jan 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2646-2011 FDA Unclassified (pre-2012) initiated 19 May 2011

    Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)

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  • Withdrawn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
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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