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510(k) K033109

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS by Scient'X — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2004
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Scient'X

  • K071261 — ISOBAR SEMI-RIGID DUAL DAMPENER (April 17, 2008)
  • K062912 — SCIENT'X SPINAL SYSTEM (February 5, 2007)
  • K052763 — STELLA CERVICAL PLATE (November 10, 2005)
  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K050348 — CO VERTEBRAL BODY REPLACEMENT (May 27, 2005)
  • K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS (May 23, 2005)
  • K043001 — MX POLYAXIAL PEDICLE SCREW (December 1, 2004)
  • K042964 — MX MONOAXIAL PEDICLE SCREW (November 22, 2004)
  • K042317 — CERVICAL PLATE (September 24, 2004)
  • K040747 — ALADYN RIGID SPINE PLATE (June 17, 2004)

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  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)