Duns Number:085049749
Device Description: A physical guide that is composed of patient's bony anatomy and allows for precise locatio A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
Catalog Number
-
Brand Name
VSP Orthopedics
Version/Model Number
Patient Tibia Drilling Guide
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
b9361d7d-5640-4407-82cd-a811c0409bf4
Public Version Date
December 04, 2020
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 |