FIREFLY® Pedicle Screw Navigation Guide— 510(k) K162419

Substantially Equivalent

Mighty Oak Medical, Inc.

FDA 510(k) clearance K162419 for FIREFLY® Pedicle Screw Navigation Guide, Substantially Equivalent on 2016-10-28. Applicant: Mighty Oak Medical, Inc..

Clearance details

Applicant: Mighty Oak Medical, Inc.
Product code: Code PQC
Advisory panel: Orthopedic
Date received: 2016-08-30
Decision date: 2016-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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