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CorticaLINK 80-4001

by Linkspine, Inc.

CorticaLINK 80-4001 is a Class II device made by Linkspine, Inc., cleared under FDA 510(k) K160722 on 7 Jul 2016 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00817329020004), 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

510(k) K160722

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817329020004 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160722 Date7 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160722 decided 7 Jul 2016 Active
  • FDA GUDID UDI-DI 00817329020004 listed 30 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160722
  2. Listed FDA GUDID 00817329020004

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CorticaLINK
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
80-4001
Primary DI / UDI-DI
00817329020004
510(k) Number
FDA product code
MNH, MNI, NKB
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K160722)

and 8 more cleared under K160722

Similar devices

Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

Other devices from Linkspine, Inc.

See all devices from Linkspine, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)