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510(k) K140716

OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE by Interventional Spine, Inc. — Product Code MAX

K140716 is an FDA 510(k) premarket notification submitted by Interventional Spine, Inc. for the device "OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE". The FDA issued a decision of Substantially Equivalent on November 24, 2014. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Interventional Spine, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2014
Date Received
March 21, 2014
Clearance Type
Traditional
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.

  • K160464 — Opticage(R) Expandable Interbody Fusion Device (April 4, 2016)
  • K152156 — Opticage Expandable Interbody Fusion Device (October 19, 2015)
  • 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)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)

FDA data resources