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510(k) K092659

SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 by Spinal USA — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
August 28, 2009
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

Other clearances by Spinal USA

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  • K130279 — REFORM PEDICLE SCREW SYSTEM (June 20, 2013)
  • K130445 — VAULT ALIF SYSTEM (April 25, 2013)
  • K122931 — S-LOK PSS SYSTEM (November 20, 2012)
  • K121172 — REFORM PEDICLE SCREW SYSTEM (August 8, 2012)
  • K112748 — SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM (July 11, 2012)
  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)

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