Duns Number:079398589
Device Description: Ø10.5 x 45mm Modular Bone Screw, Non-Fluted
Catalog Number
39-SG-1045
Brand Name
Reform TI Pedicle Screw System
Version/Model Number
39-SG-1045
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
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
K150856
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
462e82c0-78b5-4513-8089-f6e5b0da3cc9
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
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 | 1423 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
| U | Unclassified | 26 |