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Anteralign Spinal System with Titan nanoLock Surface technology

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
Anteralign Spinal System with Titan nanoLock Surface technology FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
TRIAL 46812608 6DG 20W 8X60MM FDA UDI
Model / Reference
46812608 FDA UDI
Description
TRIAL 46812608 6DG 20W 8X60MM FDA UDI

Identifiers

Primary DI / UDI-DI
00763000193713 FDA UDI
510(k) Number
K212524 FDA UDI
K214011 FDA UDI
FDA Product Code
MAX FDA UDI
OVD FDA UDI
OLO FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Anteralign Spinal System with Titan nanoLock Surface technology by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K212524 also covers:

K214011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 912ccb70-2216-48b9-bee9-7f58cc31c6ec 35 fields · synced May 30, 2026