510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864788Substantially Equivalent

Exactech Total Hip Instruments

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

K864788 is the FDA 510(k) clearance record for EXACTECH TOTAL HIP INSTRUMENTS, cleared for Exactech, Inc. on . FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K864788.

Clearance record

Decision date
Received
(21 days to decision)
Review panel
Unknown
Applicant
Exactech, Inc. 2210 NW 28th St., Gainesville FL
Third party review
No