Duns Number:697730638
Device Description: Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.
Catalog Number
27-500-200
Brand Name
Foundation®
Version/Model Number
27-500-200
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
K111087,K111087
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
4641e9fe-031b-4447-84be-4827cbb022b6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
14560245656811
Quantity per Package
5
Contains DI Package
04560245656814
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |