COLORADO 2™ Spinal System 8638104

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00721902071102 UDI-DI	Date5 Aug 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-0125-2008 FDA Unclassified (pre-2012) initiated 10 Sep 2007
Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: COLORADO 2™ Spinal System
Generic Name: Bone-screw internal spinal fixation system hook
Model / Reference: 8638104

Primary DI / UDI-DI: 00721902071102
510(k) Number: K991031
FDA Product Code: KWQ, MNI, MNH, KWP
GMDN Term: Bone-screw internal spinal fixation system hook

Device Class: Class II
Regulation Number: 888.3060, 888.3070, 888.3050
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No