510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132735Substantially Equivalent

Axia Radial Head System

Imds (Innovative MEdical Device Systems) - Leis ME, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132735 is the FDA 510(k) clearance record for AXIA RADIAL HEAD SYSTEM, a class II device, cleared for Imds (Innovative MEdical Device Systems) - Leis ME on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list one 510(k) clearance for Imds (Innovative MEdical Device Systems) - Leis ME. As of , FDA records show no recalls naming K132735.

Clearance record

Decision date
Received
(126 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Imds (Innovative MEdical Device Systems) - Leis ME 2710 Discovery Dr., Suite 600, Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWI

Trailing 12 months
1 clearance under product code KWI in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260