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510(k) K990307

OMNI-FIX, NAIL SYSTEM by Turnkey Intergration USA, Inc. — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1999
Date Received
February 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Turnkey Intergration USA, Inc.

  • K991405 — OMNI-FIX, HUMERAL NAIL (June 29, 1999)
  • K990523 — B2C, ESPACE REVISION CUP SYSTEM (April 30, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)
  • K970284 — ARTOS, DIPLOS SYSTEM (April 21, 1997)
  • K970084 — LINK CERCLAGE WIRE SYSTEM (March 13, 1997)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K943986 — LINK ENDO MODEL REVISION CUP (July 5, 1995)
  • K951355 — LINK SADDLE PROTHESIS (May 25, 1995)
  • K950397 — SYSTEM 22 VALVE (April 14, 1995)
  • K940297 — UNIVERSAL WRIST (February 6, 1995)

Other clearances for product code KTW

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  • K171606 — AOS Anterolateral Proximal Humeral Plate (June 22, 2017)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
  • K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (March 20, 2008)
  • K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (November 13, 2006)
  • K023360 — LEFORTE SYSTEM BONE PLATE (October 25, 2002)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)