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510(k) K160464

Opticage(R) Expandable Interbody Fusion Device by Interventional Spine, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2016
Date Received
February 19, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Interventional Spine, Inc.

  • K152156 — Opticage Expandable Interbody Fusion Device (October 19, 2015)
  • K140716 — OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE (November 24, 2014)
  • K133583 — OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 (February 10, 2014)
  • K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 (September 19, 2013)
  • K113527 — OPTICAGE INTERBODY FUSION DEVICE (January 20, 2012)
  • K090767 — PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER (June 11, 2009)
  • K082795 — SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (December 12, 2008)

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