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510(k) K991405

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

K991405 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "OMNI-FIX, HUMERAL NAIL". The FDA issued a decision of Substantially Equivalent on June 29, 1999. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1999
Date Received
April 22, 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.

  • K990523 — B2C, ESPACE REVISION CUP SYSTEM (April 30, 1999)
  • K990307 — OMNI-FIX, NAIL SYSTEM (April 1, 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

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • 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)
  • K012634 — REPROCESSED EXTERNAL FIXATION DEVICE (June 24, 2002)

FDA data resources