Denali Spine System

510(k) K042635

Denali Spine System is a Class II device made by K2m, LLC, cleared under FDA 510(k) K042635 on 10 Jan 2005, active as of 22 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 22 Oct 2026

Documents

510(k) K042635↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK042635	Date10 Jan 2005Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K042635

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K042635
FDA product code: KWP

Device class: Class II
Regulation: 21 CFR Part 888.3050
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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