FDA 510(k)

CRESCENT Spinal System

K-Number: K171031 · 2017-07-06

Decision Date2017-07-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CRESCENT Spinal System is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-07-06 under approval number K171031. 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 Spinal System?

CRESCENT Spinal System is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K171031.

When was CRESCENT Spinal System approved by the FDA?

CRESCENT Spinal System received FDA 510(k) clearance on 2017-07-06, under approval number K171031.

What company makes CRESCENT Spinal System?

CRESCENT Spinal System is manufactured by Medtronic Sofamor Danek.

What is the FDA product code for CRESCENT Spinal System?

The FDA product code for CRESCENT Spinal System is MAX.

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Other Devices by Medtronic Sofamor Danek

K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device K173125T2 STRATOSPHERE Expandable Corpectomy System K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium K171468FUSE Spinal System K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.