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: Surgical saw blade, sagittal, single-use FDA UDI
Device Name: Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile) FDA UDI
Model / Reference: P99-151-P301-S FDA UDI
Description: Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile) FDA UDI

Identifiers

Catalog Number: P99-151-P301-S FDA UDI
Primary DI / UDI-DI: 00889795129048 FDA UDI
FDA Product Code: GFA FDA UDI
GMDN Term: Surgical saw blade, sagittal, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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: Surgical saw blade, sagittal, single-use

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

Similar devices

Also classified as Surgical saw blade, sagittal, single-use.

IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
De Soutter Medical — De Soutter Medical, Ltd. · Class I
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
Stryker Performance Series — Stryker Corp. · Class I
IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KG · Class I
IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I

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 a5c960d4-aaf4-4538-bd8a-b56ffcc5dd5b 34 fields · synced Jun 8, 2026