510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K853763Substantially Equivalent

Tendon Stripper

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

K853763 is the FDA 510(k) clearance record for TENDON STRIPPER, 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 K853763.

Clearance record

Decision date
Received
(28 days to decision)
Review panel
Unknown
Applicant
Orthopedic Systems, Inc. 1897 National Ave., Hayward CA
Third party review
No