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FDA 510(k)

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

K-Number: K171107 · 2017-09-26

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2017-09-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2017-09-26 under approval number K171107. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System?

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System is a medical device that received FDA 510(k) clearance on 2017-09-26. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K171107.

When was CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System approved by the FDA?

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System received FDA 510(k) clearance on 2017-09-26, under approval number K171107.

What company makes CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System?

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System?

The FDA product code for CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System is MAX.

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Related PubMed Literature

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Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

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Related Devices (Code: MAX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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