Duns Number:107105876
Device Description: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 30mm
Catalog Number
174617730
Brand Name
SUMMIT
Version/Model Number
174617730
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K030103,K151885,K190895
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
b7bdab00-0cd9-459b-b796-f6a2d727a77f
Public Version Date
March 31, 2020
Public Version Number
6
DI Record Publish Date
September 24, 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 | 5839 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
| U | Unclassified | 20 |