Duns Number:078352849
Device Description: Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone bl Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocksTatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill.
Catalog Number
EZ-Bone Fixation Screw Kit
Brand Name
Tatum Surgical Bone Fixation Screw Kit
Version/Model Number
E-Z bone Fixation Screw Kit
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
K141764
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
3cd90f1b-78f6-4cc7-a6b8-7356ba4cdfac
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
November 13, 2020
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |