Activmotion S DTO CAT3.5L46D-ST

GUDID 03700569654665

NEWCLIP TECHNICS

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03700569654665
• NIH Device Record Key: 9ec6a6ae-9d5c-473e-815b-a3ea36bd88a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activmotion S DTO
• Version Model Number: CAT3.5L46D-ST
• Catalog Number: CAT3.5L46D-ST
• Company DUNS: 263281904
• Company Name: NEWCLIP TECHNICS
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700569654665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202803

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Activmotion S DTO]

• 03700569654702: CAT3.5L50D-ST
• 03700569654689: CAT3.5L48D-ST
• 03700569654665: CAT3.5L46D-ST
• 03700569654627: CAT3.5L42D-ST
• 03700569654603: CAT3.5L40D-ST
• 03700569654580: CAT3.5L38D-ST
• 03700569654566: CAT3.5L36D-ST
• 03700569654542: CAT3.5L34D-ST
• 03700569654528: CAT3.5L32D-ST
• 03700569654504: CAT3.5L30D-ST
• 03700569654481: CAT3.5L28D-ST
• 03700569654467: CAT3.5L26D-ST
• 03700569654443: CAT3.5L24D-ST
• 03700569654429: CAT3.5L22D-ST
• 03700569654405: CAT3.5L20D-ST
• 03700569654399: CAT3.5L20D