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Fcd-2 Implant System

FDA UDI

Class U (US FDA UDI)

by Decima Spine, Inc.

Identity

Trade Name
FCD-2 IMPLANT SYSTEM FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
FCD-2 Implant System, ANCHOR FDA UDI
Model / Reference
9063 FDA UDI
Description
FCD-2 Implant System, ANCHOR FDA UDI

Identifiers

Catalog Number
9063-00 FDA UDI
Primary DI / UDI-DI
00857360007190 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Fcd-2 Implant System by Decima Spine, 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Decima Spine, Inc.

Sources (1)

  • FDA UDI ffa73873-4f70-42f5-96c7-e4d431f8a1aa 35 fields · synced May 30, 2026