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510(k) K142264

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

K142264 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "Valeo C Spacer System, Valeo II C IBF Device". The FDA issued a decision of Substantially Equivalent on December 8, 2014. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Amedica Corp. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code ODP

  • 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)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources