Duns Number:058614483
Device Description: Bio Absorbable ACL Soft Tissue Femoral Fixation Implant
Catalog Number
2030SS
Brand Name
BioStratis
Version/Model Number
2030SS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 14, 2018
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
K041961
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
ea0eb239-6590-484c-b255-533cf3b9727a
Public Version Date
April 02, 2020
Public Version Number
5
DI Record Publish Date
January 05, 2018
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |