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
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K943277Substantially Equivalent

Link Saddle Prothesis

Turnkey Intergration USA, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943277 is the FDA 510(k) clearance record for LINK SADDLE PROTHESIS, cleared for Turnkey Intergration USA, Inc. on . FDA records list 26 510(k) clearances for Turnkey Intergration USA, Inc., from to . As of , FDA records show no recalls naming K943277.

Clearance record

Decision date
Received
(203 days to decision)
Review panel
Unknown
Applicant
Turnkey Intergration USA, Inc. 6060 Castleway Dr. W., Indianapolis IN
Third party review
No