10 X 77.5MM SI FUSION FASTENER CANN 202-10077

GUDID 00810097803336

10 X 77.5MM SI FUSION FASTENER CANN

Osteocentric Technologies, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00810097803336
• NIH Device Record Key: 22e72f6d-acd8-4197-9d42-833b0c02d5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10 X 77.5MM SI FUSION FASTENER CANN
• Version Model Number: 202-10077
• Catalog Number: 202-10077
• 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

Device Dimensions

• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 77.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097803336 [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

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

[00810097803336]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by Osteocentric Technologies, Inc.

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• 00810074307543 - 6.0 x 60mm Bone Screw Fastener ST: 2025-10-06 6.0 x 60mm Bone Screw Fastener ST
• 00810074307550 - 6.0 x 65mm Bone Screw Fastener ST: 2025-10-06 6.0 x 65mm Bone Screw Fastener ST
• 00810074308984 - 11 X 75mm LAG FASTENER: 2025-09-30 11 X 75mm LAG FASTENER
• 00810074309974 - 11 X 80mm LAG FASTENER: 2025-09-30 11 X 80mm LAG FASTENER
• 00810074309981 - 11 X 85mm LAG FASTENER: 2025-09-30 11 X 85mm LAG FASTENER
• 00810074309998 - 11 X 90mm LAG FASTENER: 2025-09-30 11 X 90mm LAG FASTENER
• 00810189110007 - 11 X 95mm LAG FASTENER: 2025-09-30 11 X 95mm LAG FASTENER