510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K810644Substantially Equivalent

Hoffman Hoop Device

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

K810644 is the FDA 510(k) clearance record for HOFFMAN HOOP DEVICE, 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 K810644.

Clearance record

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