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510(k) K142005

SpineFab Vertebral Body Replacement (VBR) System by Oxford Performance Materials — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2015
Date Received
July 23, 2014
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 Oxford Performance Materials

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  • K161052 — OsteoFab Patient Specific Facial Device (July 20, 2016)
  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (February 7, 2013)

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  • 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)