Duns Number:691435666
Device Description: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.
Catalog Number
ORB-0120B
Brand Name
ReBOSSIS
Version/Model Number
2.0g
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 11, 2018
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
K142090
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
8b7c9ccf-417a-459d-a7fb-8054b7170972
Public Version Date
November 12, 2018
Public Version Number
4
DI Record Publish Date
September 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |