510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K113364Substantially Equivalent

2.7Mm Lcp Ulna Osteotomy System

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

K113364 is the FDA 510(k) clearance record for 2.7MM LCP ULNA OSTEOTOMY SYSTEM, a class II device, cleared for Synthes (USA) Products, LLC on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 479 510(k) clearances for Synthes (USA) Products, LLC, from to . As of , FDA records show one recall naming K113364.

Clearance record

Decision date
Received
(106 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (USA) Products, LLC 1230 Wilson Dr., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRS

Trailing 12 months
59 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20261