Duns Number:830350380
Device Description: SLEEVE NAV5599015 5.5/6.0 RMAS ASSEMBLD
Catalog Number
-
Brand Name
CD HORIZON® Spinal System
Version/Model Number
NAV5599015
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
K201407
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
39cca8f3-940b-4bae-8190-a6370311fc79
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 24, 2020
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |