Duns Number:830350380
Device Description: Bone Screw, Locking, 3.5mm x 13mm
Catalog Number
-
Brand Name
ENDOSKELETON® TCS Sterile Barrier System
Version/Model Number
5302-3513-S
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
K192018,K173535,K183557,K191565
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
ce69a761-ecc6-4723-94c2-93ea30188040
Public Version Date
March 02, 2022
Public Version Number
4
DI Record Publish Date
September 30, 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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |