Duns Number:085049749
Device Description: A three dimensional physical model depicting patient specific modified anatomy. To be use A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
Catalog Number
-
Brand Name
VSP Orthopedics
Version/Model Number
Autograft Orthopedic Model
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190044
Product Code
PBF
Product Code Name
Orthopaedic Surgical Planning And Instrument Guides
Public Device Record Key
ff14d323-2a76-4701-8320-fad727cbd0b6
Public Version Date
November 27, 2019
Public Version Number
2
DI Record Publish Date
September 11, 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. | 146 |