Home / 510(k) Clearances / K102544

510(k) K102544

SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY by Smith & Nephew Inc., Endoscopy Div. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2011
Date Received
September 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Smith & Nephew Inc., Endoscopy Div.

  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K111843 — ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM (November 14, 2011)
  • K092551 — SMITH & NEPHEW INSTRUMENT TRAYS (September 14, 2010)
  • K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR (April 19, 2010)
  • K093943 — BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM (March 5, 2010)
  • K093897 — SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR (March 4, 2010)
  • K073551 — SMITH & NEPHEW INSTRUMENT TRAYS (May 21, 2008)
  • K080358 — PLLA, HA SCREW (April 23, 2008)
  • K063726 — PLC SUTURE ANCHOR (March 6, 2007)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)