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510(k) K180822

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System by Wenzel Spine, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
March 30, 2018
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 Wenzel Spine, Inc.

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  • K231076 — VariLift®-C Interbody Fusion System (September 27, 2023)
  • K231807 — primaLOK™ SP Interspinous Fusion System (August 15, 2023)
  • K151900 — VariLift-L Interbody Fusion Device (December 11, 2015)
  • K131296 — VARILIFT-L INTERBODY FUSION DEVICE (September 3, 2013)
  • K120603 — VARILIFT -C (January 29, 2013)
  • K111123 — VARILIFT CERVICAL INTERBODY FUSION SYSTEM (December 8, 2011)
  • K100820 — WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM (August 5, 2010)

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