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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
Lumbar interspinous decompression instrument set, reusable FDA UDI
Device Name
PARALLEL COMPRESSOR, BLK DIAMOND FDA UDI
Model / Reference
1010-1010 FDA UDI
Description
PARALLEL COMPRESSOR, BLK DIAMOND FDA UDI

Identifiers

Catalog Number
1010-1010 FDA UDI
Primary DI / UDI-DI
B06210101010 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
GMDN Term
Lumbar interspinous decompression instrument set, reusable 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

No

FDA UDI

Single Use

Yes

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

No

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: Lumbar interspinous decompression instrument set, reusable

Black Diamond Pedicle Screw System by Osseus Fusion Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar interspinous decompression instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osseus Fusion Systems Llc

Sources (1)

  • FDA UDI fe109628-55f2-4a1d-95db-9555b44aba5d 35 fields · synced May 31, 2026