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510(k) K073430

VALEO PEDICLE SCREW SPINAL SYSTEM by Amedica Corp. — Product Code NKB

K073430 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "VALEO PEDICLE SCREW SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 29, 2008. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Amedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2008
Date Received
December 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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)
  • 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)
  • K073505 — MODIFICATION TO VALEO VBR (January 9, 2008)
  • K073125 — VALEO VBR (December 5, 2007)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources