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FacetLINK MI

FDA UDI

Class U (US FDA UDI)

by Linkspine, Inc.

Identity

Trade Name
FacetLINK MI FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Dilator 2 FDA UDI
Model / Reference
80-2502 FDA UDI
Description
Dilator 2 FDA UDI

Identifiers

Catalog Number
80-2502 FDA UDI
Primary DI / UDI-DI
00817329024477 FDA UDI
510(k) Number
K123497 FDA UDI
FDA Product Code
MRW FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
U 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: Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI by Linkspine, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K123497 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Linkspine, Inc.

Sources (1)

  • FDA UDI 5026ccf8-8e17-4b44-a3e9-41c7a2747503 36 fields · synced Jun 8, 2026