MODIFICATION TO STAXX FX SYSTEM— 510(k) K063606

Name: FDA 510(k) clearance K063606
Creator: U.S. Food and Drug Administration
Published: 2007-04-13

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K063606 for MODIFICATION TO STAXX FX SYSTEM, Substantially Equivalent on 2007-04-13. Applicant: Spine Wave, Inc.. Device class: 2.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code OBL
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2006-12-01
Decision date: 2007-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

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