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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 46821220 MD 12DG 32X25X20MM FDA UDI
Model / Reference
46821220 FDA UDI
Description
TRIAL 46821220 MD 12DG 32X25X20MM FDA UDI

Identifiers

Primary DI / UDI-DI
00763000147525 FDA UDI
510(k) Number
K214010 FDA UDI
FDA Product Code
MAX FDA UDI
OVD FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

K214010 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 5e76b58d-3340-4bba-a6ab-7409c551bd6b 35 fields · synced Jun 8, 2026