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510(k) K141500

OPTIO-C ANTERIOR CERVICAL SYSTEM by Zimmer Spine, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2014
Date Received
June 6, 2014
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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  • K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (October 29, 2014)
  • K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM (June 2, 2014)
  • K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)
  • K133184 — ARDIS INTERBODY SYSTEM (January 30, 2014)

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