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510(k) K050861

PEEK CAS by Interpore Cross Intl. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2005
Date Received
April 5, 2005
Clearance Type
Special
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 Interpore Cross Intl.

  • K031399 — INTERGRO DBM (February 18, 2005)
  • K041407 — TITANIUM MESH IMPLANT (December 29, 2004)
  • K043229 — MODIFICATION TO ALTIUS OCT SYSTEM (December 21, 2004)
  • K042798 — C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM (November 4, 2004)
  • K040928 — EXPANDABLE PEEK VBR IMPLANT (August 27, 2004)
  • K041794 — C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM (July 19, 2004)
  • K041449 — SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SE (July 1, 2004)
  • K033961 — ALTIUS OCT SYSTEM (April 14, 2004)
  • K040168 — MODIFICATION TO GEO STRUCTURE (April 8, 2004)
  • K031772 — TI FENESTRATED PLATE (September 5, 2003)

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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)