510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182285Substantially Equivalent

PK High Tibial Osteotomy Correction System

Paonan Biotech Co., Ltd, Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182285 is the FDA 510(k) clearance record for PK High Tibial Osteotomy Correction System, a class II device, cleared for Paonan Biotech Co., Ltd. on under FDA product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component). FDA records list 6 510(k) clearances for Paonan Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K182285.

Clearance record

Decision date
Received
(301 days to decision)
Product code
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Paonan Biotech Co., Ltd. 3f, # 50, Ln.. 258, Rueiguang Rd.., Neihu District, Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTW

Trailing 12 months

FDA records hold no clearances under product code KTW in the trailing twelve months.

FDA records show no clearances under product code KTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KTW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260