Step Boss

FDA UDI

Class II (US FDA UDI)

by Biomedical Enterprises, Inc.

Identity

Trade Name: Step Boss FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Device Name: Step Boss 20X30X30X06 W2X3 FDA UDI
Model / Reference: 461-0620 FDA UDI
Description: Step Boss 20X30X30X06 W2X3 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810633020975 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 06 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI

Category: Orthopaedic bone staple, non-adjustable

Step Boss by Biomedical Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple, non-adjustable.

MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Elite — Synthes · Class II
MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Speed Arc — Synthes · Class II
JAWS Nitinol Staple System — Paragon 28 · Class II
Speed — Synthes · Class II
GEO Staple System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomedical Enterprises, Inc.

Sources (1)

FDA UDI f835bb08-6443-4b2f-b3c1-47cd9fb73b5c 35 fields · synced May 31, 2026