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DTRAX® Spinal System

FDA UDI

Class II (US FDA UDI)

by Providence Medical Technology, Inc.

Identity

Trade Name
DTRAX® Spinal System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion. FDA UDI
Model / Reference
DX-22-100 FDA UDI
Description
The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion. FDA UDI

Identifiers

Catalog Number
DX-22-100 FDA UDI
Primary DI / UDI-DI
00852776006089 FDA UDI
510(k) Number
K180876 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 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

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, single-use

DTRAX® Spinal System by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Providence Medical Technology, Inc.

Sources (1)

  • FDA UDI a0b1a72a-e599-4d5d-b787-195186a81dc5 35 fields · synced May 30, 2026