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
K862157Substantially Equivalent

Omc Orthomet Cannulated Screw

Orthomet, Inc., Minneapolis MN / Traditional, Substantially Equivalent

K862157 is the FDA 510(k) clearance record for OMC ORTHOMET CANNULATED SCREW, cleared for Orthomet, Inc. on . FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K862157.

Clearance record

Decision date
Received
(85 days to decision)
Review panel
Unknown
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
Third party review
No