ROMEO 2 PAD POSTERIOR AXIAL DEVICE— 510(k) K141508

Substantially Equivalent

Spineart

FDA 510(k) clearance K141508 for ROMEO 2 PAD POSTERIOR AXIAL DEVICE, Substantially Equivalent on 2014-08-21. Applicant: Spineart. Device class: 2.

Clearance details

Applicant: Spineart
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-06-06
Decision date: 2014-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

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