MODIFICATION TO STAXX FX SYSTEM— 510(k) K063606

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..

Clearance details

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

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