Black Dimaond POCT 2420-1150

GUDID B06224201150

3.5x150mm Rod, Straight, Black Diamond POCT

Osseus Fusion Systems, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B06224201150
• NIH Device Record Key: 18ecf329-47ac-43d3-a4b7-c220ec263407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Dimaond POCT
• Version Model Number: 2420-1150
• Catalog Number: 2420-1150
• Company DUNS: 933442068
• Company Name: Osseus Fusion Systems, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06224201150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222107

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

[B06224201150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by Osseus Fusion Systems, LLC

• B06224200000 - Black Diamond POCT: 2023-06-22 Locking Cap, Black Diamond POCT
• B06224200001 - Black Diamond POCT: 2023-06-22 Locking Cap, HH Connector, Black Diamond POCT
• B06224200002 - Black Diamond POCT: 2023-06-22 Locking Cap Nut, HH Connector, Black Diamond POCT
• B06224200025 - Black Diamond POCT: 2023-06-22 3.5x25mm Rod, Curved, Black Diamond POCT
• B06224200030 - Black Diamond POCT: 2023-06-22 3.5x30mm Rod, Curved, Black Diamond POCT
• B06224200035 - Black Diamond POCT: 2023-06-22 3.5x35mm Rod, Curved, Black Diamond POCT
• B06224200040 - Black Diamond POCT: 2023-06-22 3.5x40mm Rod, Curved, Black Diamond POCT
• B06224200045 - Black Diamond POCT: 2023-06-22 3.5x45mm Rod, Curved, Black Diamond POCT