Sectra Orthopedic Package

GUDID 07350092810227

Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images.

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810227
• NIH Device Record Key: 92e5961c-2d09-46e4-a6fc-c9dfef928b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Orthopedic Package
• Version Model Number: 12.2
• Company DUNS: 354117848
• Company Name: Sectra AB
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031590

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-12-03

On-Brand Devices [Sectra Orthopedic Package]

• 07350092810111: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810081: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810043: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810029: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810227: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810258: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810364: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810401: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810432: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810463: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810494: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki