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510(k) K182285

PK High Tibial Osteotomy Correction System by Paonan Biotech Co., Ltd. — Product Code KTW

K182285 is an FDA 510(k) premarket notification submitted by Paonan Biotech Co., Ltd. for the device "PK High Tibial Osteotomy Correction System". The FDA issued a decision of Substantially Equivalent on June 20, 2019. 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. Paonan Biotech Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2019
Date Received
August 23, 2018
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 Paonan Biotech Co., Ltd.

  • K220261 — NEST-C Interbody System (April 24, 2023)
  • K180230 — NEST Interbody System (January 25, 2019)
  • K180228 — II-Type Intervertebral Spacer (January 11, 2019)
  • K180226 — TREND II Spinal Fixation System- STEP Series (July 25, 2018)
  • K161225 — Paonan Armstrong Posterior Spinal Fixation System (August 11, 2017)

Other clearances for product code KTW

  • 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)
  • K012634 — REPROCESSED EXTERNAL FIXATION DEVICE (June 24, 2002)

FDA data resources