510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133285Substantially Equivalent

Stryker Temporary Condylar Prosthesis

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133285 is the FDA 510(k) clearance record for STRYKER TEMPORARY CONDYLAR PROSTHESIS, a class II device, cleared for Stryker on under FDA product code NEI (Prosthesis, Condyle, Mandibular, Temporary). FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K133285.

Clearance record

Decision date
Received
(166 days to decision)
Product code
NEI Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
Device class
Class II
Review panel
Dental
Applicant
Stryker 750 Trade Centre Way, Portage MI
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