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510(k) K112748

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM by Spinal USA, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2012
Date Received
September 21, 2011
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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  • 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)
  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)
  • K092659 — SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (November 17, 2009)

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