Klockner Surgical Box

510(k) Number

K173642 ↗

FDA product code

KCT

Device class

Class II

Regulation

21 CFR Part 880.6850

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

• InterActive Complete Surgical Tray by IMPLANT DIRECT SYBRON MANUFACTURING LLC
• S.I.N. Instrument Kits by S.I.N. - Sistema DE Implante Nacional S.A.
• SMITH & NEPHEW INSTRUMENT TRAYS by Smith & Nephew, Inc.
• Straumann Surgical Cassettes Surgically Invasive Instruments 040.500 by Institut Straumann AG
• MYOSURE INTRUMENT TRAY by Hologic, Inc.
• STERILIZATION BAG, POLYESTER/WRAP by Cgs Supplies Corp.
• 9102762030 9102-762-030 by Stryker Corp.
• EZ-TRAXTM Persona Knee Containment Device by K1 Medical, LLC
• Advanced Imaging Modality (AIM) Sterilization Tray by PARAGON MEDICAL, INC.
• SURGICAL KIT KCSW 02 by S.I.N. - Sistema DE Implante Nacional S.A.

• Implant Mount Ø4.7mm [Ec · 1]

  Class IIa

  CE/MDR

• Implant Mount Ø4.7mm [NV · 1]

  Class IIa

  CE/MDR

• Implant Mount Ø4.2mm [Mv · 4]

  Class IIa

  CE/MDR

• Implant Mount Ø4.2mm [NV · 4]

  Class IIa

  CE/MDR

See all devices from Soadco, S.L. →