Duns Number:354117848
Device Description: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning 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.
Catalog Number
-
Brand Name
Sectra Orthopedic Package
Version/Model Number
16.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031590
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
bab7fd5f-2c09-4dcd-a34b-603699c03d55
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 33 |