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510(k) K152460

Rectangular Corpectomy Cage by Amendia, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
August 28, 2015
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 Amendia, Inc.

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  • K152972 — Amendia Stand-Alone Cervical System (January 14, 2016)
  • K151310 — Amendia Interbody Fusion Devices (January 6, 2016)
  • K152455 — Amendia Cervical Plate System (October 15, 2015)
  • K151322 — Amendia Interbody Fusion Devices (September 10, 2015)
  • K150395 — Omega LIF System (August 10, 2015)

Other clearances for product code MQP

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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)