FDA 510(k)

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium

K-Number: K172199 · 2017-09-19

Decision Date2017-09-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K172199. 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 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K172199.

When did ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium receive FDA 510(k) clearance?

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172199.

Who is the listed applicant for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

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

What is the FDA product code for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

The FDA product code for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium is MAX.

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Official Source

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