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510(k) K133802

AIS MODULIFT VBR SYSTEM by Aesculap Implant System, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2014
Date Received
December 13, 2013
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 Aesculap Implant System, Inc.

  • K142707 — AIS Odontoid Fracture Fixation System (December 19, 2014)
  • K142150 — AIS MODULIFT VBR SYSTEM (October 29, 2014)
  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
  • K123909 — AESCULAP CESPACE XP (April 15, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)
  • K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (July 23, 2010)

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)