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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K842626Substantially Equivalent

Hip Prosthesis Pack

DeRoyal Industries, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842626 is the FDA 510(k) clearance record for HIP PROSTHESIS PACK, cleared for Deroyal Industries, Inc. on . FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K842626.

Clearance record

Decision date
Received
(110 days to decision)
Review panel
Unknown
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
Third party review
No