COSINE™ Spacer

by Globus Medical, Inc.

510(k) K234035

COSINE™ Spacer is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K234035 on 6 Sep 2024, 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) K234035↗

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 · Traditional	NumberK234035	Date6 Sep 2024Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K234035

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K234035
FDA product code: MAX

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

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