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510(k) K001614

STRYKER TRAUMA PELVIC SET by Howmedica Osteonics Corp. — Product Code KTW

K001614 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "STRYKER TRAUMA PELVIC SET". The FDA issued a decision of Substantially Equivalent on August 4, 2000. 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. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2000
Date Received
May 25, 2000
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 Howmedica Osteonics Corp.

  • K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (August 13, 2020)
  • K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Tri (May 13, 2020)
  • K130895 — REUNION RSA SHOULDER SYSTEM (December 27, 2013)
  • K123604 — ABG III MONOLITHIC HIP STEM (August 16, 2013)
  • K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CI (February 22, 2013)
  • K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON A (February 14, 2013)
  • K122853 — NOVEL FIT AND FILL STEM (February 1, 2013)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
  • K121308 — HIP SYSTEMS (July 30, 2012)
  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)

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