Black Diamond Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Osseus Fusion Systems Llc

Identity

Trade Name: Black Diamond Pedicle Screw System FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: T25 SCREW, STD PED, NON-CANN, 4.5x50mm, BLK DIAMOND FDA UDI
Model / Reference: 1-1001-4550 FDA UDI
Description: T25 SCREW, STD PED, NON-CANN, 4.5x50mm, BLK DIAMOND FDA UDI

Identifiers

Catalog Number: 1-1001-4550 FDA UDI
Primary DI / UDI-DI: B062110014550 FDA UDI
FDA Product Code: MNI FDA UDI
MNH FDA UDI
GMDN Term: Tissue saturation oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 50 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI

Category: Tissue saturation oximeter

Black Diamond Pedicle Screw System by Osseus Fusion Systems Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Osseus Fusion Systems Llc

Sources (1)

FDA UDI a57e80fc-ca12-4e2e-a020-d73d846a2683 35 fields · synced May 30, 2026