FDA 510(k), K081917, DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS

FDA 510(k), K081917, DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS

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510(K) Number: K081917
Device Name: DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
Manufacturer: SHARON STAROWICZ
Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation Number: MAX
Classification Product Code: KXA
Date Received: 07/03/2008
Decision Date: 05/22/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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