DYNAMIS™ Implant System SI13550-S

GUDID 10810152101923

DYNAMIS™ SCREW DIA 13.5 X 50MM

PROMETHEAN RESTORATIVE LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 10810152101923
• NIH Device Record Key: 447555b0-f157-4af2-ac6c-ca94c0b27357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNAMIS™ Implant System
• Version Model Number: SI13550-S
• Catalog Number: SI13550-S
• Company DUNS: 124592779
• Company Name: PROMETHEAN RESTORATIVE 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: true
• 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: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com
• Phone: 720-512-5947
• Email: info@prometheanrestorative.com

Device Dimensions

• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 13.5 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810152101923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243565

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: 2025-03-13
• Device Publish Date: 2025-03-05

On-Brand Devices [DYNAMIS™ Implant System]

• 10810152102005: DYNAMIS™ SCREW DIA 13.5 X 90MM
• 10810152101992: DYNAMIS™ SCREW DIA 13.5 X 85MM
• 10810152101985: DYNAMIS™ SCREW DIA 13.5 X 80MM
• 10810152101978: DYNAMIS™ SCREW DIA 13.5 X 75MM
• 10810152101961: DYNAMIS™ SCREW DIA 13.5 X 70MM
• 10810152101954: DYNAMIS™ SCREW DIA 13.5 X 65MM
• 10810152101947: DYNAMIS™ SCREW DIA 13.5 X 60MM
• 10810152101930: DYNAMIS™ SCREW DIA 13.5 X 55MM
• 10810152101923: DYNAMIS™ SCREW DIA 13.5 X 50MM
• 10810152101916: DYNAMIS™ SCREW DIA 13.5 X 45MM
• 10810152101909: DYNAMIS™ SCREW DIA 13.5 X 40MM
• 10810152101893: DYNAMIS™ SCREW DIA 13.5 X 35MM
• 10810152101886: DYNAMIS™ SCREW DIA 12.5 X 90MM
• 10810152101879: DYNAMIS™ SCREW DIA 12.5 X 85MM
• 10810152101862: DYNAMIS™ SCREW DIA 12.5 X 80MM
• 10810152101855: DYNAMIS™ SCREW DIA 12.5 X 75MM
• 10810152101848: DYNAMIS™ SCREW DIA 12.5 X 70MM
• 10810152101831: DYNAMIS™ SCREW DIA 12.5 X 65MM
• 10810152101824: DYNAMIS™ SCREW DIA 12.5 X 60MM
• 10810152101817: DYNAMIS™ SCREW DIA 12.5 X 55MM
• 10810152101800: DYNAMIS™ SCREW DIA 12.5 X 50MM
• 10810152101794: DYNAMIS™ SCREW DIA 12.5 X 45MM
• 10810152101787: DYNAMIS™ SCREW DIA 12.5 X 40MM
• 10810152101770: DYNAMIS™ SCREW DIA 12.5 X 35MM
• 10810152101763: DYNAMIS™ SCREW DIA 11.5 X 90MM
• 10810152101756: DYNAMIS™ SCREW DIA 11.5 X 85MM
• 10810152101749: DYNAMIS™ SCREW DIA 11.5 X 80MM
• 10810152101732: DYNAMIS™ SCREW DIA 11.5 X 75MM
• 10810152101725: DYNAMIS™ SCREW DIA 11.5 X 70MM
• 10810152101718: DYNAMIS™ SCREW DIA 11.5 X 65MM
• 10810152101701: DYNAMIS™ SCREW DIA 11.5 X 60MM
• 10810152101695: DYNAMIS™ SCREW DIA 11.5 X 55MM
• 10810152101688: DYNAMIS™ SCREW DIA 11.5 X 50MM
• 10810152101671: DYNAMIS™ SCREW DIA 11.5 X 45MM
• 10810152101664: DYNAMIS™ SCREW DIA 11.5 X 40MM
• 10810152101657: DYNAMIS™ SCREW DIA 11.5 X 35MM
• 10810152101640: DYNAMIS™ SCREW DIA 10.5 X 90MM
• 10810152101633: DYNAMIS™ SCREW DIA 10.5 X 85MM
• 10810152101626: DYNAMIS™ SCREW DIA 10.5 X 80MM
• 10810152101619: DYNAMIS™ SCREW DIA 10.5 X 75MM
• 10810152101602: DYNAMIS™ SCREW DIA 10.5 X 70MM
• 10810152101596: DYNAMIS™ SCREW DIA 10.5 X 65MM
• 10810152101589: DYNAMIS™ SCREW DIA 10.5 X 60MM
• 10810152101572: DYNAMIS™ SCREW DIA 10.5 X 55MM
• 10810152101565: DYNAMIS™ SCREW DIA 10.5 X 50MM
• 10810152101558: DYNAMIS™ SCREW DIA 10.5 X 45MM
• 10810152101541: DYNAMIS™ SCREW DIA 10.5 X 40MM
• 10810152101534: DYNAMIS™ SCREW DIA 10.5 X 35MM
• 10810152101527: DYNAMIS™ SCREW DIA 9.5 X 90MM
• 10810152101510: DYNAMIS™ SCREW DIA 9.5 X 85MM