FACET SCREW SYSTEM— 510(k) K130863

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K130863 for FACET SCREW SYSTEM, Substantially Equivalent on 2013-08-09. Applicant: Spinal USA. Device class: Unclassified.

Clearance details

Applicant: Spinal USA
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-03-28
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spinal USA

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K130445 — VAULT ALIF SYSTEM2013-04-25
K122931 — S-LOK PSS SYSTEM2012-11-20

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