12 x 50mm SI Fusion Fastener Cann Sterile 202-12050-S

GUDID 00810097801509

12 x 50mm SI Fusion Fastener Cann Sterile

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

• Primary Device ID: 00810097801509
• NIH Device Record Key: 933818d1-2a9a-4bc4-968e-00d08a25b57e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12 x 50mm SI Fusion Fastener Cann Sterile
• Version Model Number: 202-12050-S
• Catalog Number: 202-12050-S
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC 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

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

Device Dimensions

• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097801509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161755

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-25
• Device Publish Date: 2022-08-17

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• 00810074300049 - 4.0 x 20mm Screw Super Fastener, ST: 2023-06-20 4.0 x 20mm Screw Super Fastener, ST
• 00810074300056 - 4.0 x 22mm Screw Super Fastener, ST: 2023-06-20 4.0 x 22mm Screw Super Fastener, ST
• 00810074300063 - 4.0 x 24mm Screw Super Fastener, ST: 2023-06-20 4.0 x 24mm Screw Super Fastener, ST
• 00810074300070 - 4.0 x 26mm Screw Super Fastener, ST: 2023-06-20 4.0 x 26mm Screw Super Fastener, ST