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MiniBunion

FDA UDI

Class I (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name
MiniBunion FDA UDI
Generic Name
Surgical drill guide obturator FDA UDI
Device Name
The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI
Model / Reference
MiniBunion Saw Guide FDA UDI
Description
The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI

Identifiers

Catalog Number
280041 FDA UDI
Primary DI / UDI-DI
00815432029228 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical drill guide obturator 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: Surgical drill guide obturator

MiniBunion by Crossroads Extremity Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide obturator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crossroads Extremity Systems Llc

Sources (1)

  • FDA UDI d8d74dab-8bc1-421f-a691-c85e956e6c41 34 fields · synced May 30, 2026