Karma® Fixation System— 510(k) K190289

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K190289 for Karma® Fixation System, Substantially Equivalent on 2019-04-03. Applicant: Spinal Elements, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2019-02-11
Decision date: 2019-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.