Black Diamond POCT 2420-3520

GUDID B06224203520

3.5x20mm Screw, Drilling, Black Diamond POCT

Osseus Fusion Systems, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B06224203520
• NIH Device Record Key: 3deebc57-0e16-4900-b3c1-bd2baea25084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Diamond POCT
• Version Model Number: 2420-3520
• Catalog Number: 2420-3520
• 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	B06224203520 [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

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

Moist Heat or Steam Sterilization

[B06224203520]

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

On-Brand Devices [Black Diamond POCT]

• B06224204538: 4.5x38mm Screw, Drilling, Black Diamond POCT
• B06224204536: 4.5x36mm Screw, Drilling, Black Diamond POCT
• B06224204534: 4.5x34mm Screw, Drilling, Black Diamond POCT
• B06224204532: 4.5x32mm Screw, Drilling, Black Diamond POCT
• B06224204530: 4.5x30mm Screw, Drilling, Black Diamond POCT
• B06224204528: 4.5x28mm Screw, Drilling, Black Diamond POCT
• B06224204526: 4.5x26mm Screw, Drilling, Black Diamond POCT
• B06224204524: 4.5x24mm Screw, Drilling, Black Diamond POCT
• B06224203522: 3.5x22mm Screw, Drilling, Black Diamond POCT
• B06224203520: 3.5x20mm Screw, Drilling, Black Diamond POCT
• B06224203518: 3.5x18mm Screw, Drilling, Black Diamond POCT
• B06224203516: 3.5x16mm Screw, Drilling, Black Diamond POCT
• B06224203514: 3.5x14mm Screw, Drilling, Black Diamond POCT
• B06224203512: 3.5x12mm Screw, Drilling, Black Diamond POCT
• B06224203510: 3.5x10mm Screw, Drilling, Black Diamond POCT
• B06224203509: 3.5x08mm Screw, Tapping, Black Diamond POCT
• B06224200160: 3.5x160mm Rod, Curved, Black Diamond POCT
• B06224200150: 3.5x150mm Rod, Curved, Black Diamond POCT
• B06224200140: 3.5x140mm Rod, Curved, Black Diamond POCT
• B06224200130: 3.5x130mm Rod, Curved, Black Diamond POCT
• B06224200120: 3.5x120mm Rod, Curved, Black Diamond POCT
• B06224200115: 3.5x115mm Rod, Curved, Black Diamond POCT
• B06224200110: 3.5x110mm Rod, Curved, Black Diamond POCT
• B06224200105: 3.5x105mm Rod, Curved, Black Diamond POCT
• B06224200100: 3.5x100mm Rod, Curved, Black Diamond POCT
• B06224200095: 3.5x95mm Rod, Curved, Black Diamond POCT
• B06224200090: 3.5x90mm Rod, Curved, Black Diamond POCT
• B06224200085: 3.5x85mm Rod, Curved, Black Diamond POCT
• B06224200080: 3.5x80mm Rod, Curved, Black Diamond POCT
• B06224200075: 3.5x75mm Rod, Curved, Black Diamond POCT
• B06224200070: 3.5x70mm Rod, Curved, Black Diamond POCT
• B06224200065: 3.5x65mm Rod, Curved, Black Diamond POCT
• B06224200060: 3.5x60mm Rod, Curved, Black Diamond POCT
• B06224200055: 3.5x55mm Rod, Curved, Black Diamond POCT
• B06224200050: 3.5x50mm Rod, Curved, Black Diamond POCT
• B06224200045: 3.5x45mm Rod, Curved, Black Diamond POCT
• B06224200040: 3.5x40mm Rod, Curved, Black Diamond POCT
• B06224200035: 3.5x35mm Rod, Curved, Black Diamond POCT
• B06224200030: 3.5x30mm Rod, Curved, Black Diamond POCT
• B06224200025: 3.5x25mm Rod, Curved, Black Diamond POCT
• B06224200002: Locking Cap Nut, HH Connector, Black Diamond POCT
• B06224200001: Locking Cap, HH Connector, Black Diamond POCT
• B06224200000: Locking Cap, Black Diamond POCT