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Fortress Pedicular Fixation

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Fortress Pedicular Fixation FDA UDI
Generic Name
Joint prosthesis implantation kit, reusable FDA UDI
Device Name
Set Screw Placer, Handled FDA UDI
Model / Reference
64-03-02 FDA UDI
Description
Set Screw Placer, Handled FDA UDI

Identifiers

Catalog Number
641-0068 FDA UDI
Primary DI / UDI-DI
M7406410068 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Joint prosthesis implantation kit, reusable 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
MRI Safety
MR Unsafe FDA UDI

Category: Joint prosthesis implantation kit, reusable

Fortress Pedicular Fixation by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 0516ed79-34b0-4b9e-8977-b7a440575719 35 fields · synced Jun 6, 2026