Duns Number:830350380
Device Description: SCREW PK2 G73733132018 4.0X18 SLF-DR VAR
Catalog Number
-
Brand Name
ATLANTIS ESSENTIALS™ Anterior Cervical Plate System
Version/Model Number
G73733132018
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2019
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
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
K152623,K152623
Product Code
KWQ
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Public Device Record Key
603138a1-8a1e-4873-a037-c24eb068dd42
Public Version Date
June 27, 2019
Public Version Number
4
DI Record Publish Date
January 11, 2016
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 |