510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062789Substantially Equivalent

Synthes (USA) Rapid Resorbable Fixation System

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

K062789 is the FDA 510(k) clearance record for SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code JEY (Plate, Bone). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 3 recalls naming K062789.

Clearance record

Decision date
Received
(162 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Synthes (Usa) 1230 Wilson Dr., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260