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510(k) K091044

SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM by Spinal USA — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2009
Date Received
April 13, 2009
Clearance Type
Special
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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  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)

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