Home / 510(k) Clearances / K032527

510(k) K032527

HEDROCEL VERTEBRAL BODY REPLACEMENT by Implex Corp. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2003
Date Received
August 15, 2003
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 Implex Corp.

  • K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (September 23, 2005)
  • K051196 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 (June 17, 2005)
  • K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTS (December 21, 2004)
  • K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ (September 30, 2004)
  • K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX (July 14, 2004)
  • K031962 — NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS (January 8, 2004)
  • K033384 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ (November 19, 2003)
  • K032344 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (October 2, 2003)
  • K031449 — MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOU (September 23, 2003)
  • K032282 — MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (August 21, 2003)

Other clearances for product code MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • 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)