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510(k) K070922

MODIFICATION TO SPINAL USA VBR SYSTEM by Spinal USA — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2007
Date Received
April 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K121172 — REFORM PEDICLE SCREW SYSTEM (August 8, 2012)
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  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)

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