VertebraLINK 84-0002/0606

by Linkspine, Inc.

VertebraLINK 84-0002/0606 is a Class II device made by Linkspine, Inc., cleared under FDA 510(k) K162693 on 29 Mar 2017 and listed in FDA GUDID since 17 May 2018 (UDI-DI 00817329020851), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817329020851 UDI-DI	Date17 May 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK162693	Date29 Mar 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817329020851
FDA 510(k) database 510(k) number K162693

Across registries

2 registries list this device

FDA 510(k) K162693 decided 29 Mar 2017 Active
FDA GUDID UDI-DI 00817329020851 listed 17 May 2018 Listed

Timeline

2 dated events

29 Mar 2017 Cleared FDA 510(k) K162693
17 May 2018 Listed FDA GUDID 00817329020851

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VertebraLINK
Generic name: Polymeric spinal fusion cage, sterile
Model / Ref / Catalog: 84-0002/0606

Primary DI / UDI-DI: 00817329020851
510(k) Number: K162693
FDA product code: MAX
GMDN term: Polymeric spinal fusion cage, sterile

Device class: Class II
Regulation number: 888.3080
GUDID distribution status: In Commercial Distribution

Size: Height — 6 Millimeter
Length — 22 Millimeter
Width — 8 Millimeter
Angle — 6 degree

Other devices from Linkspine, Inc.

See all devices from Linkspine, Inc. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)