Duns Number:623316978
Device Description: Bayonetted Awl Guide, 2.5mm
Catalog Number
5210-1065
Brand Name
ENDOSKELETON® TCS
Version/Model Number
5210-1065
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2021
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
K142940
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
417a2142-1325-4df2-a885-4b8b5934569d
Public Version Date
October 21, 2022
Public Version Number
5
DI Record Publish Date
December 15, 2016
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 | 243 |
2 | A medical device with a moderate to high risk that requires special controls. | 5255 |