Home / 510(k) Clearances / K843554

510(k) K843554

BONE SCREWS by Mecron Medical Products, Inc. — Product Code KTW

K843554 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "BONE SCREWS". The FDA issued a decision of Substantially Equivalent on October 1, 1984. 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. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
September 10, 1984
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 Mecron Medical Products, Inc.

  • K861138 — MASH DERMATOME (April 14, 1986)
  • K854191 — MECRON UNCEMENTED STRUCTURED STEM HIP (November 13, 1985)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)
  • K844774 — EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS (April 22, 1985)
  • K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS (March 12, 1985)
  • K844487 — MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (February 19, 1985)
  • K844486 — MECRON MRC-HEADLESS FEMORAL COMPONENT (February 19, 1985)
  • K844773 — EFF-EFFNER BULBS (January 8, 1985)
  • K843449 — AUTODYNAMIC COMPRESSION HIP SCREW-PLATE (October 22, 1984)
  • K843553 — BONE PLATES (October 1, 1984)

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)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)

FDA data resources