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
K823398Substantially Equivalent

Lateral Positioner

Mizuho Orthopedic Systems Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823398 is the FDA 510(k) clearance record for LATERAL POSITIONER, cleared for Orthopedic Systems, Inc. on . FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K823398.

Clearance record

Decision date
Received
(12 days to decision)
Review panel
Unknown
Applicant
Orthopedic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No