Duns Number:688322841
Device Description: BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive poro BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Catalog Number
-
Brand Name
BoneMedik, 4~6mm, 5cc
Version/Model Number
9529
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070897
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
dc79bdf3-9fd5-477e-9238-324ee3419931
Public Version Date
January 24, 2022
Public Version Number
5
DI Record Publish Date
September 19, 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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |