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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K864337Substantially Equivalent

Segmental Spinal Instrumentation System

Kirschner Medical Corp., Timonium MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864337 is the FDA 510(k) clearance record for SEGMENTAL SPINAL INSTRUMENTATION SYSTEM, cleared for Kirschner Medical Corp. on . FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K864337.

Clearance record

Decision date
Received
(42 days to decision)
Review panel
Unknown
Applicant
Kirschner Medical Corp. 9690 Deereco Rd.D, Timonium MD
Third party review
No