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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2017-09-26 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K171107.

When did CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 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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