The Solstice OCT System

by Life Spine, Inc. 2 variants

510(k) K170804

The Solstice OCT System is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K170804 on 18 May 2017, 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) K170804↗

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	NumberK170804	Date18 May 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K170804

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K170804
FDA product code: NKG

Device class: Class II
Regulation: 21 CFR Part 888.3075
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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Class II

See all devices from Life Spine, Inc. →