Duns Number:109903521
Device Description: OSTEORAPTOR 2.9 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 OSTEORAPTOR 2.9 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLUE
Catalog Number
72201994
Brand Name
OSTEORAPTOR
Version/Model Number
72201994
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K151105
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
1f8f10e7-9a28-458a-a56f-f309bbb29efc
Public Version Date
October 22, 2020
Public Version Number
7
DI Record Publish Date
September 21, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |