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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K844377Substantially Equivalent

Silicone

Treace Medical, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844377 is the FDA 510(k) clearance record for SILICONE, cleared for Treace Medical, Inc. on . FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K844377.

Clearance record

Decision date
Received
(125 days to decision)
Review panel
Unknown
Applicant
Treace Medical, Inc. Suite 400, Memphis TN
Third party review
No