Duns Number:424382307
Device Description: The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lactic) Acid and Calcium Phosphate, which will be gradually resorbed into the body, this function however, is patient dependant.
Catalog Number
234-010-180
Brand Name
Biosteon® Screw
Version/Model Number
234-010-180
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
-
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
64675a19-53ec-40f9-a979-8a350dbe156c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2015
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |