Duns Number:600170232
Device Description: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone graftingmaterial i OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone graftingmaterial intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix iscomposed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen,which is derived from veterinary certified pigs and is purified and cross-linked.
Catalog Number
OXB0250
Brand Name
OSSIX™ Bone
Version/Model Number
0.250 cc
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
K163714
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
1390ac83-265a-4ee2-b927-a67c7d3bad04
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |