Sectra Orthopedic Package

GUDID 07350092810401

Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810401
• NIH Device Record Key: edc2f1c1-9d41-4df4-bd86-0a1a5bd650af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Orthopedic Package
• Version Model Number: 16.1
• 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
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com
• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810401 [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: 2022-05-11
• Device Publish Date: 2022-05-03

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
• 07350092810555: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki