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FDA 510(k), K170108, Xultan 5.5 Pedicle Screw System
FDA 510(k), K170108, Xultan 5.5 Pedicle Screw System
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510(K) Number: K170108
Device Name: Xultan 5.5 Pedicle Screw System
Manufacturer: Dan Gerbec
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: NKB
Classification Product Code: KXA
Date Received: 01/12/2017
Decision Date: 05/02/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Xultan 5.5 Pedicle Screw System
Manufacturer: Dan Gerbec
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: NKB
Classification Product Code: KXA
Date Received: 01/12/2017
Decision Date: 05/02/2017
Decision: Substantially Equivalent (SESE)
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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