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510(k) K073505

MODIFICATION TO VALEO VBR by Amedica Corp. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2008
Date Received
December 13, 2007
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 Amedica Corp.

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  • K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System (October 2, 2015)
  • K142264 — Valeo C Spacer System, Valeo II C IBF Device (December 8, 2014)
  • K142347 — Amedica Valeo II Interbody Fusion Device (November 18, 2014)
  • K121892 — PHANTOM PLUS CERAMIC CAGE SYSTEM (August 24, 2012)
  • K091278 — VALEO SPACER SYSTEM (January 28, 2010)
  • K082037 — SEEPLATE CERVICAL PLATE SYSTEM (September 26, 2008)
  • K073430 — VALEO PEDICLE SCREW SPINAL SYSTEM (January 29, 2008)
  • K073125 — VALEO VBR (December 5, 2007)

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