510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863215Substantially Equivalent

Fasciculated I Rod

The Deca Co., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863215 is the FDA 510(k) clearance record for FASCICULATED I ROD, cleared for The Deca Co. on . FDA records list 7 510(k) clearances for The Deca Co., from to . As of , FDA records show no recalls naming K863215.

Clearance record

Decision date
Received
(126 days to decision)
Review panel
Unknown
Applicant
The Deca Co. P.O. Box 1997, Costa Mesa CA
Third party review
No