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FDA 510(k), K122872, INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k), K122872, INTERVERTEBRAL BODY FUSION DEVICE
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510(K) Number: K122872
Device Name: INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer: DIO MEDICAL CO., LTD.
Device Classification Name: intervertebral fusion device with bone graft, cervical
Regulation Number: 888.3080
Classification Product Code: ODP
Date Received: 09/19/2012
Decision Date: 02/28/2013
Regulation Medical Specialty: Orthopedic
Device Name: INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer: DIO MEDICAL CO., LTD.
Device Classification Name: intervertebral fusion device with bone graft, cervical
Regulation Number: 888.3080
Classification Product Code: ODP
Date Received: 09/19/2012
Decision Date: 02/28/2013
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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