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510(k) K090048

ASFORA BULLET CAGE SYSTEM by Medical Designs, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2009
Date Received
January 7, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Medical Designs, LLC

  • K182352 — SP-LINK™ System (November 21, 2018)
  • K181591 — Fixated Asfora BULLET CAGE® (FABC) (September 26, 2018)
  • K143688 — ASFORA ANTERIOR CERVICAL PLATE SYSTEM (July 1, 2015)
  • K112648 — ASFORA BULLET CAGE (March 13, 2012)
  • K042359 — SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS- (November 17, 2004)
  • K002970 — SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 (December 12, 2000)

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