SImmetry Implant, 12.5mm x 85mm

GUDID 04260636675010

Paradigm Spine GmbH

Sacroiliac joint transarticular fixation/arthrodesis implant, coated

• Primary Device ID: 04260636675010
• NIH Device Record Key: c9765393-edcb-445d-9e03-96244b283f61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SImmetry Implant, 12.5mm x 85mm
• Version Model Number: 10-P12585-01
• Company DUNS: 537619731
• Company Name: Paradigm Spine GmbH
• 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: true
• Expiration Date: true
• 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
GS1	04260636675010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151818

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: 2021-02-02
• Device Publish Date: 2021-01-25

Devices Manufactured by Paradigm Spine GmbH

• 04260636678998 - coflex instrument loaner set: 2023-04-10 instrument loaner set
• 04260636678912 - CoFix instrument loaner set: 2021-06-29
• 04260636678929 - CoFix implant loaner set: 2021-06-29
• 04260636673467 - SImmetry, Blunt Pin, 3.2mm: 2021-02-02
• 04260636673474 - SImmetry, Impactor: 2021-02-02
• 04260636673481 - SImmetry, Long Pin, 3.2mm: 2021-02-02
• 04260636673498 - SImmetry, Short Pin, 3.2mm: 2021-02-02
• 04260636673504 - SImmetry, Working Cannula: 2021-02-02