SImmetry, #2 Decorticator

GUDID 04260636673634

Paradigm Spine GmbH

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 04260636673634
• NIH Device Record Key: bd4768c9-76e6-4c3b-b7d7-a00bbb5437c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SImmetry, #2 Decorticator
• Version Model Number: ZYG-10122
• 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: false
• 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
GS1	04260636673634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151818

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

[04260636673634]

Moist Heat or Steam Sterilization

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