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510(k) K161405

Valeo II Interbody Fusion Device System by Amedica Corp. — Product Code MAX

K161405 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "Valeo II Interbody Fusion Device System". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), 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
August 19, 2016
Date Received
May 20, 2016
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 Amedica Corp.

  • K173453 — Valeo® C+CSC with Lumen Interbody Fusion Device (March 5, 2018)
  • K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System (October 2, 2015)
  • K142264 — Valeo C Spacer System, Valeo II C IBF Device (December 8, 2014)
  • 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 MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources