510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837776Substantially Equivalent

Aor X-Ray Aligment Pad

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837776 is the FDA 510(k) clearance record for AOR X-RAY ALIGMENT PAD, a class I device, cleared for Zimmer, Inc. on under FDA product code IXJ (Grid, Radiographic). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K837776.

Clearance record

Decision date
Received
(229 days to decision)
Product code
IXJ Grid, Radiographic
Regulation
21 CFR 892.1910
Device class
Class I
Review panel
Radiology
Applicant
Zimmer, Inc. 727 N. Detroit St., Warsaw IN
Third party review
No

Clearances, product code IXJ

Trailing 12 months

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

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