Duns Number:081067703
Device Description: Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collag Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
Catalog Number
BF-10P
Brand Name
Bi-Ostetic Foam Putty
Version/Model Number
BF-10P
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
K092046
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
16b82b67-a96f-47c7-99dd-a15a04d71996
Public Version Date
October 13, 2020
Public Version Number
1
DI Record Publish Date
October 05, 2020
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. | 178 |