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510(k) K093675

INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 by Vertebral Technologies, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2009
Date Received
November 27, 2009
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 Vertebral Technologies, Inc.

  • K131540 — INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE (September 3, 2013)
  • K110226 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (May 27, 2011)
  • K110045 — INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE (February 3, 2011)
  • K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (October 6, 2010)
  • K091988 — MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 (July 30, 2009)
  • K080673 — INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE (June 10, 2008)

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