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510(k) K262595

VariLift-C Cervical Interbody Fusion System by Wenzel Spine, Inc. — Product Code ODP

K262595 is an FDA 510(k) premarket notification submitted by Wenzel Spine, Inc. for the device "VariLift-C Cervical Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on August 26, 2026. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Wenzel Spine, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2026
Date Received
July 27, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Wenzel Spine, Inc.

  • K250247 — panaSIa SI Fusion System (July 9, 2025)
  • K231076 — VariLift®-C Interbody Fusion System (September 27, 2023)
  • K231807 — primaLOK™ SP Interspinous Fusion System (August 15, 2023)
  • K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (January 28, 2019)
  • 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)

Other clearances for product code ODP

  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)

FDA data resources