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510(k) K142264

Valeo C Spacer System, Valeo II C IBF Device by Amedica Corp. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2014
Date Received
August 15, 2014
Clearance Type
Traditional
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 Amedica Corp.

  • K173453 — Valeo® C+CSC with Lumen Interbody Fusion Device (March 5, 2018)
  • K161405 — Valeo II Interbody Fusion Device System (August 19, 2016)
  • K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System (October 2, 2015)
  • K142347 — Amedica Valeo II Interbody Fusion Device (November 18, 2014)
  • K121892 — PHANTOM PLUS CERAMIC CAGE SYSTEM (August 24, 2012)
  • K091278 — VALEO SPACER SYSTEM (January 28, 2010)
  • K082037 — SEEPLATE CERVICAL PLATE SYSTEM (September 26, 2008)
  • K073430 — VALEO PEDICLE SCREW SPINAL SYSTEM (January 29, 2008)
  • K073505 — MODIFICATION TO VALEO VBR (January 9, 2008)
  • K073125 — VALEO VBR (December 5, 2007)

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  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)