510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080109Substantially Equivalent

Synthes (USA) Modular Blade Plate System

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080109 is the FDA 510(k) clearance record for SYNTHES (USA) MODULAR BLADE PLATE SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 56 recalls naming K080109.

Clearance record

Decision date
Received
(65 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
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
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