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FDA 510(k), K082926, ZUMA, MODEL 55-XXXX/56-XXXX
FDA 510(k), K082926, ZUMA, MODEL 55-XXXX/56-XXXX
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510(K) Number: K082926
Device Name: ZUMA, MODEL 55-XXXX/56-XXXX
Manufacturer: JEFF BRITTAN
Device Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation Number: OVD
Classification Product Code: KXA
Date Received: 10/01/2008
Decision Date: 12/22/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ZUMA, MODEL 55-XXXX/56-XXXX
Manufacturer: JEFF BRITTAN
Device Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation Number: OVD
Classification Product Code: KXA
Date Received: 10/01/2008
Decision Date: 12/22/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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