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Xpress Minimally Invasive Pedicle Screw System

FDA UDI

Class I (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name
Xpress Minimally Invasive Pedicle Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
EXTENSION RELEASE TOOL ASSEMBLY FDA UDI
Model / Reference
T073-1800 FDA UDI
Description
EXTENSION RELEASE TOOL ASSEMBLY FDA UDI

Identifiers

Primary DI / UDI-DI
M697T07318001 FDA UDI
FDA Product Code
HWB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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: Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xtant Medical Holdings, Inc.

Sources (1)

  • FDA UDI 18a361a9-85ab-4c00-b27f-a37e75b3e1a4 34 fields · synced May 30, 2026