510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K843778Substantially Equivalent

Mayo Elbow II

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

K843778 is the FDA 510(k) clearance record for MAYO ELBOW II, cleared for Zimmer, Inc. on . FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K843778.

Clearance record

Decision date
Received
(161 days to decision)
Review panel
Unknown
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No