510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852555Substantially Equivalent

Splintrex

Allison Forge Corp., Brookline MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852555 is the FDA 510(k) clearance record for SPLINTREX, cleared for Allison Forge Corp. on . FDA records list one 510(k) clearance for Allison Forge Corp. As of , FDA records show no recalls naming K852555.

Clearance record

Decision date
Received
(11 days to decision)
Review panel
Unknown
Applicant
Allison Forge Corp. P.O. Box 767, Brookline MA
Third party review
No