osmium™, ADDplus™ CS 1301-24T

GUDID 04052536002528

Cancellous bone screw, ø 4.0 mm, length 24 mm

Ulrich GmbH & Co. KG

Spinal fixation plate, non-bioabsorbable Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 04052536002528
• NIH Device Record Key: c902d321-6f46-4071-b8c2-657a3eec3689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osmium™, ADDplus™
• Version Model Number: CS 1301-24T
• Catalog Number: CS 1301-24T
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536002528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090841

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

[04052536002528]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [osmium™, ADDplus™]

• 04052536090570: osmium screw incl. bolt grey, Ø 4.0 mm, length 12 mm
• 04052536006854: osmium screw incl. bolt blue, Ø 4.0 mm, length 18 mm
• 04052536006847: osmium screw incl. bolt green, Ø 4.0 mm, length 16 mm
• 04052536006830: osmium screw incl. bolt gold, Ø 4.0 mm, length 14 mm
• 04052536002535: Cancellous bone screw, ø 4.0 mm, length 26 mm
• 04052536002528: Cancellous bone screw, ø 4.0 mm, length 24 mm
• 04052536002511: Cancellous bone screw, ø 4.0 mm, length 22 mm
• 04052536002504: Cancellous bone screw, ø 4.0 mm, length 20 mm
• 04052536002498: Cancellous bone screw, ø 4.0 mm, length 18 mm
• 04052536002481: Cancellous bone screw, ø 4.0 mm, length 16 mm
• 04052536002474: Cancellous bone screw, ø 4.0 mm, length 14 mm
• 04052536002467: Cancellous bone screw, ø 4.0 mm, length 12 mm
• 04052536002450: osmium screw incl. bolt, blue, ø 5.0 mm, length 18 mm
• 04052536002443: osmium screw incl. bolt, green, ø 5.0 mm, length 16 mm
• 04052536002436: osmium screw incl. bolt, gold, ø 5.0 mm, length 14 mm