OsteoCrete® Bone Void Filler 44-050-00-STR
GUDID B4474405000STR0
OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
Bone matrix implant, synthetic| Primary Device ID | B4474405000STR0 |
| NIH Device Record Key | e6865b49-06ca-47da-bbca-32b77e31b763 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoCrete® Bone Void Filler |
| Version Model Number | 5cc |
| Catalog Number | 44-050-00-STR |
| Company DUNS | 003506272 |
| Company Name | BONE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4474405000STR0 [Primary] |
FDA Product Code
| MQV | Filler, Bone Void, Calcium Compound |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2020-02-19 |
On-Brand Devices [OsteoCrete® Bone Void Filler]
| B4474415000BSI2 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474410000BSI1 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474405000BSI0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474415000STR0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474415000BSI0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474410000STR0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474410000BSI0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
| B4474405000STR0 | OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V |
Trademark Results [OsteoCrete]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOCRETE 78753093 not registered Dead/Abandoned |
Bone Solutions, Inc. 2005-11-14 |
 OSTEOCRETE 77618145 4150440 Live/Registered |
Bone Solutions, Inc. 2008-11-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.