Duns Number:080307067
Device Description: Superelastic Nitinol Implant System Style B 15 x 15 x 15mm
Catalog Number
DB-15-1515-SB1
Brand Name
DynaBridge
Version/Model Number
DB-15-1515-SB
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
K181815
Product Code
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
8ffea63c-078d-40be-8fae-7ae9757ee8fb
Public Version Date
May 07, 2019
Public Version Number
1
DI Record Publish Date
April 29, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1516 |