510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960538Substantially Equivalent

Opteon Unipolar

Exactech, Inc., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960538 is the FDA 510(k) clearance record for OPTEON UNIPOLAR, a class II device, cleared for Exactech, Inc. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K960538.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Exactech, Inc. 4613 NW 6th St., Suite D, Gainesville FL
510(k) summary
Summary
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260