Duns Number:424382307
Device Description: geneX® putty consists of an inorganic framework of calcium based ions. geneX® Putty has be geneX® putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile.
Catalog Number
920-005
Brand Name
geneX® Putty
Version/Model Number
920-005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 02, 2020
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
K073341
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
d798b97e-9b6a-4c6d-81f4-f85c6a62028f
Public Version Date
November 02, 2020
Public Version Number
4
DI Record Publish Date
April 01, 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 |