Duns Number:003489810
Device Description: Saxxony, Fixed Drill Guide, 12mm
Catalog Number
-
Brand Name
SAXXONY™ Posterior Cervical Thoracic System
Version/Model Number
I12-812
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182508
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
09d74389-741a-4cf7-9aa5-a51ff786854a
Public Version Date
June 14, 2021
Public Version Number
2
DI Record Publish Date
March 22, 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 |
---|---|---|
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 |