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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K243461Substantially Equivalent

Calibrate Interbody Systems

Alphatec Spine, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243461 is the FDA 510(k) clearance record for Calibrate Interbody Systems, cleared for Alphatec Spine, Inc. on . FDA records list 121 510(k) clearances for Alphatec Spine, Inc., from to . As of , FDA records show no recalls naming K243461.

Clearance record

Decision date
Received
(116 days to decision)
Review panel
Unknown
Applicant
Alphatec Spine, Inc. 1950 Camino Vida Roble, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No