Chesapeake Spinal System

by K2M, Inc. 3 variants

510(k) K092211

Chesapeake Spinal System is a Class II device made by K2M, Inc., cleared under FDA 510(k) K092211 on 5 Mar 2010, 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) K092211↗

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	NumberK092211	Date5 Mar 2010Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K092211

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K092211
FDA product code: OVD

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

Other devices from K2M, Inc.

See all devices from K2M, Inc. →