Bun-Yo-Matic™ Lapidus Clamp System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Bun-Yo-Matic™ Lapidus Clamp System FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: Bun-Yo-Matic, Wire Tube FDA UDI
Model / Reference: P30-960-1208 FDA UDI
Description: Bun-Yo-Matic, Wire Tube FDA UDI

Identifiers

Catalog Number: P30-960-1208 FDA UDI
Primary DI / UDI-DI: 00889795129277 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 9648ef29-9d1f-46a1-9ac4-05af240e3fc8 34 fields · synced Jun 1, 2026