Duns Number:486711679
Device Description: T15 SYNFIX DRIVER 40 DEGREE DOUBLE WOBBLE
Catalog Number
SD03802434
Brand Name
SynFix
Version/Model Number
SD03.802.434
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
K072253
Product Code
OVD
Product Code Name
Intervertebral fusion device with integrated fixation, lumbar
Public Device Record Key
1e8c976d-202f-4f07-8935-39d8739fa7c3
Public Version Date
July 14, 2022
Public Version Number
6
DI Record Publish Date
September 14, 2015
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |