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FDA 510(k), K082037, SEEPLATE CERVICAL PLATE SYSTEM
FDA 510(k), K082037, SEEPLATE CERVICAL PLATE SYSTEM
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510(K) Number: K082037
Device Name: SEEPLATE CERVICAL PLATE SYSTEM
Manufacturer: ADAM HERDER
Device Classification Name: Appliance, Fixation, Spinal Intervertebral Body
Regulation Number: KWQ
Classification Product Code: KXA
Date Received: 07/17/2008
Decision Date: 09/26/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SEEPLATE CERVICAL PLATE SYSTEM
Manufacturer: ADAM HERDER
Device Classification Name: Appliance, Fixation, Spinal Intervertebral Body
Regulation Number: KWQ
Classification Product Code: KXA
Date Received: 07/17/2008
Decision Date: 09/26/2008
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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