510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K853205Substantially Equivalent for Some Indications

Proximal Porocoat Modified Medical Aspect Aml Hip

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent for Some Indications

K853205 is the FDA 510(k) clearance record for PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP, cleared for Depuy, Inc. on . FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K853205.

Clearance record

Decision date
Received
(47 days to decision)
Review panel
Unknown
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No