CRESCENT™ Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K171031

CRESCENT™ Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K171031 on 6 Jul 2017, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

510(k) K171031↗

FDA record

Trust

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK171031	Date6 Jul 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K171031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K171031
FDA product code: MAX
FDA applicant: Medtronic Sofamor Danek

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Other devices from Medtronic Sofamor Danek, Inc.

MSB Reusable Instruments 9870005

Class I
MSB CD HORIZON Spinal System 6530530

Class II
T2 STRATOSPHERE™ Expandable Corpectomy System 436125C

Class II
MSB SHILLA Growth Guidance System 7670431

Class II

See all devices from Medtronic Sofamor Danek, Inc. →