NILE Alternative Fixation Spinal System

510(k) K160208

NILE Alternative Fixation Spinal System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K160208 on 18 Mar 2016, 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) K160208↗

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 · Special	NumberK160208	Date18 Mar 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K160208

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K160208
FDA product code: OWI

Device class: Class II
Regulation: 21 CFR Part 888.3010
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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