510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801313Substantially Equivalent

Compression Molding of Uhmwpe

Howmedica Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801313 is the FDA 510(k) clearance record for COMPRESSION MOLDING OF UHMWPE, cleared for Howmedica Corp. on . FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K801313.

Clearance record

Decision date
Received
(6 days to decision)
Review panel
Unknown
Applicant
Howmedica Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No