FDA 510(k)

CRESCENT (R) SPINAL SYSTEM TITANIUM

K-Number: K110543 · 2011-08-09

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2011-08-09

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CRESCENT (R) SPINAL SYSTEM TITANIUM 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 2011-08-09 under 510(k) number K110543. 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 CRESCENT (R) SPINAL SYSTEM TITANIUM?

CRESCENT (R) SPINAL SYSTEM TITANIUM is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K110543.

When did CRESCENT (R) SPINAL SYSTEM TITANIUM receive FDA 510(k) clearance?

CRESCENT (R) SPINAL SYSTEM TITANIUM received FDA 510(k) clearance on 2011-08-09, under 510(k) number K110543.

Who is the listed applicant for CRESCENT (R) SPINAL SYSTEM TITANIUM?

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 CRESCENT (R) SPINAL SYSTEM TITANIUM?

The FDA product code for CRESCENT (R) SPINAL SYSTEM TITANIUM is 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.