Duns Number:003489810
Device Description: Navigated Tap, 7.5mm
Catalog Number
-
Brand Name
Nexxt Spine Navigation System
Version/Model Number
I10NAV-06-75
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K220291
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
284d66d0-b46c-41f8-b219-e6fb599aac48
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
May 25, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1102 |
2 | A medical device with a moderate to high risk that requires special controls. | 4259 |
U | Unclassified | 91 |