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FacetFuse®

FDA UDI

Class U (US FDA UDI)

by Spinefrontier, Inc.

Identity

Trade Name
FacetFuse® FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
Facet Screw Assy SW Fixed 15 Lag, 5.0x55 FDA UDI
Model / Reference
01-00007-SW5055 FDA UDI
Description
Facet Screw Assy SW Fixed 15 Lag, 5.0x55 FDA UDI

Identifiers

Primary DI / UDI-DI
00190361016755 FDA UDI
510(k) Number
K071420 FDA UDI
FDA Product Code
MRW FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

FacetFuse® by Spinefrontier, 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, sterile.

Cleared under the same submission

K071420 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinefrontier, Inc.

Sources (1)

  • FDA UDI 02813fb5-0bc2-430a-8918-136e668229d4 36 fields · synced Jun 7, 2026