HILINE Fixation System— 510(k) K230565

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K230565 for HILINE Fixation System, Substantially Equivalent on 2023-04-20. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code OWI
Advisory panel: Orthopedic
Date received: 2023-03-01
Decision date: 2023-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

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