Blue Topaz Sacroiliac Screw System 3000-12540

GUDID B062300012540

Sacroiliac Screw, 12.5x40mm, Blue Topaz

Osseus Fusion Systems, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: B062300012540
• NIH Device Record Key: 21fdad88-2d79-45c9-8a4b-3e82a51d4a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Topaz Sacroiliac Screw System
• Version Model Number: 3000-12540
• Catalog Number: 3000-12540
• 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	B062300012540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213590

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

[B062300012540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Blue Topaz Sacroiliac Screw System]

• B062300011570: Sacroiliac Screw, 11.5x70mm, Blue Topaz
• B062300011565: Sacroiliac Screw, 11.5x65mm, Blue Topaz
• B062300011560: Sacroiliac Screw, 11.5x60mm, Blue Topaz
• B062300011555: Sacroiliac Screw, 11.5x55mm, Blue Topaz
• B062300011550: Sacroiliac Screw, 11.5x50mm, Blue Topaz
• B062300011545: Sacroiliac Screw, 11.5x45mm, Blue Topaz
• B062300011540: Sacroiliac Screw, 11.5x40mm, Blue Topaz
• B062300011535: Sacroiliac Screw, 11.5x35mm, Blue Topaz
• B062300011530: Sacroiliac Screw, 11.5x30mm, Blue Topaz
• B062300010580: Sacroiliac Screw, 10.5x80mm, Blue Topaz
• B062300010575: Sacroiliac Screw, 10.5x75mm, Blue Topaz
• B062300010570: Sacroiliac Screw, 10.5x70mm, Blue Topaz
• B062300010565: Sacroiliac Screw, 10.5x65mm, Blue Topaz
• B062300010560: Sacroiliac Screw, 10.5x60mm, Blue Topaz
• B062300010555: Sacroiliac Screw, 10.5x55mm, Blue Topaz
• B062300010550: Sacroiliac Screw, 10.5x50mm, Blue Topaz
• B062300010545: Sacroiliac Screw, 10.5x45mm, Blue Topaz
• B062300010540: Sacroiliac Screw, 10.5x40mm, Blue Topaz
• B062300010535: Sacroiliac Screw, 10.5x35mm, Blue Topaz
• B062300010530: Sacroiliac Screw, 10.5x30mm, Blue Topaz
• B062300009580: Sacroiliac Screw, 9.5x80mm, Blue Topaz
• B062300009575: Sacroiliac Screw, 9.5x75mm, Blue Topaz
• B062300009570: Sacroiliac Screw, 9.5x70mm, Blue Topaz
• B062300009565: Sacroiliac Screw, 9.5x65mm, Blue Topaz
• B062300009560: Sacroiliac Screw, 9.5x60mm, Blue Topaz
• B062300009555: Sacroiliac Screw, 9.5x55mm, Blue Topaz
• B062300009550: Sacroiliac Screw, 9.5x50mm, Blue Topaz
• B062300009545: Sacroiliac Screw, 9.5x45mm, Blue Topaz
• B062300009540: Sacroiliac Screw, 9.5x40mm, Blue Topaz
• B062300009535: Sacroiliac Screw, 9.5x35mm, Blue Topaz
• B062300009530: Sacroiliac Screw, 9.5x30mm, Blue Topaz
• B062300008580: Sacroiliac Screw, 8.5x80mm, Blue Topaz
• B062300008575: Sacroiliac Screw, 8.5x75mm, Blue Topaz
• B062300008570: Sacroiliac Screw, 8.5x70mm, Blue Topaz
• B062300008565: Sacroiliac Screw, 8.5x65mm, Blue Topaz
• B062300008560: Sacroiliac Screw, 8.5x60mm, Blue Topaz
• B062300008555: Sacroiliac Screw, 8.5x55mm, Blue Topaz
• B062300008550: Sacroiliac Screw, 8.5x50mm, Blue Topaz
• B062300008545: Sacroiliac Screw, 8.5x45mm, Blue Topaz
• B062300008540: Sacroiliac Screw, 8.5x40mm, Blue Topaz
• B062300008535: Sacroiliac Screw, 8.5x35mm, Blue Topaz
• B062300008530: Sacroiliac Screw, 8.5x30mm, Blue Topaz
• B062300012580: Sacroiliac Screw, 12.5x80mm, Blue Topaz
• B062300012575: Sacroiliac Screw, 12.5x75mm, Blue Topaz
• B062300012570: Sacroiliac Screw, 12.5x70mm, Blue Topaz
• B062300012565: Sacroiliac Screw, 12.5x65mm, Blue Topaz
• B062300012560: Sacroiliac Screw, 12.5x60mm, Blue Topaz
• B062300012555: Sacroiliac Screw, 12.5x55mm, Blue Topaz
• B062300012550: Sacroiliac Screw, 12.5x50mm, Blue Topaz
• B062300012545: Sacroiliac Screw, 12.5x45mm, Blue Topaz