Fixcet Spinal Facet Screw System

FDA UDI

Class U (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Fixcet Spinal Facet Screw System FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: WASHER, FIXCET, 10mm FDA UDI
Model / Reference: X063-0022 FDA UDI
Description: WASHER, FIXCET, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI: M697X06300221 FDA UDI
FDA Product Code: MRW FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10 Millimeter FDA UDI

Category: Implantable bone washer

Fixcet Spinal Facet Screw System by Xtant Medical Holdings, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable bone washer.

ISOLA — Depuy Spine, Inc. · Class II
Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
Monster Screw System — Paragon 28 · Class II
ALPHALOK Plating System — Vilex, Inc. · Class II
Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
LEOS Cannulated Screw System — Tyber Medical · Class II
FacetLink System — WALDEMAR LINK GmbH & Co. KG · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 5f5ac7ae-eec3-43fc-82ac-27d557d664e0 35 fields · synced Jun 8, 2026