| Device |
calcium salt bone void filler, drillable, non-screw augmentation |
| Regulation Description |
Resorbable calcium salt bone void filler device. |
| Definition |
To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure.It is delivered to the defect and resorbs over time to be replaced by bone.Not for screw augmentation. |
| Physical State |
bone void filler and mixing and delivery system |
| Technical Method |
placed or injected in bony defects |
| Target Area |
various, specified bone voids (e.g., extremeties, pelvis) |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | OIS |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3045
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
