510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081747Substantially Equivalent

Modification to Synthes (USA) Condylar Head Add-on System

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

K081747 is the FDA 510(k) clearance record for MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code NEI (Prosthesis, Condyle, Mandibular, Temporary). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K081747.

Clearance record

Decision date
Received
(78 days to decision)
Product code
NEI Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
Device class
Class II
Review panel
Dental
Applicant
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEI

Trailing 12 months

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

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