8 X 65MM SI FUSION FASTENER CANN 202-08065

GUDID 00810097803091

8 X 65MM SI FUSION FASTENER CANN

Osteocentric Technologies, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00810097803091
• NIH Device Record Key: d4578370-257c-44be-8358-9ece38e41315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8 X 65MM SI FUSION FASTENER CANN
• Version Model Number: 202-08065
• Catalog Number: 202-08065
• Company DUNS: 089645059
• Company Name: Osteocentric Technologies, Inc.
• 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

Customer Support Contacts

• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097803091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230226

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

[00810097803091]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-19
• Device Publish Date: 2024-06-19

Devices Manufactured by Osteocentric Technologies, Inc.

• 00810074306416 - 7.0mm Nut: 2025-07-02 7.0mm Nut
• 00810074306423 - 8.0mm Nut: 2025-07-02 8.0mm Nut
• 00816950025518 - 3.3mm Locking Screw Fastener ST 24mm: 2025-07-02 3.3mm Locking Screw Fastener ST 24mm
• 00816950025525 - 3.3mm Locking Screw Fastener ST 26mm: 2025-07-02 3.3mm Locking Screw Fastener ST 26mm
• 00816950025532 - 3.3mm Locking Screw Fastener ST 28mm: 2025-07-02 3.3mm Locking Screw Fastener ST 28mm
• 00816950025549 - 3.3mm Locking Screw Fastener ST 30mm: 2025-07-02 3.3mm Locking Screw Fastener ST 30mm
• 00816950025556 - 3.3mm Locking Screw Fastener ST 32mm: 2025-07-02 3.3mm Locking Screw Fastener ST 32mm
• 00816950025563 - 3.3mm Locking Screw Fastener ST 34mm: 2025-07-02 3.3mm Locking Screw Fastener ST 34mm