RANGE SPINAL SYSTEM— 510(k) K131030

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K131030 for RANGE SPINAL SYSTEM, Substantially Equivalent on 2013-05-09. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code OSH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-04-12
Decision date: 2013-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, 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.