Duns Number:354117848
Device Description: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperat 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.
Catalog Number
-
Brand Name
Sectra Orthopedic Package
Version/Model Number
12.2
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
92e5961c-2d09-46e4-a6fc-c9dfef928b72
Public Version Date
December 11, 2019
Public Version Number
1
DI Record Publish Date
December 03, 2019
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 |