510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983766Substantially Equivalent

Synthes Synmesh

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983766 is the FDA 510(k) clearance record for SYNTHES SYNMESH, a class II device, cleared for Synthes (Usa) on under FDA product code EZX (Mesh, Surgical, Metal). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 14 recalls naming K983766.

Clearance record

Decision date
Received
(53 days to decision)
Product code
EZX Mesh, Surgical, Metal
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code EZX

Trailing 12 months

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

FDA records show no clearances under product code EZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZX, 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