| Device Type ID | 4619 |
| Device Name | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Regulation Description | Resorbable Calcium Salt Bone Void Filler Device. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3045 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4619 |
| Device | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Product Code | MBP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Resorbable Calcium Salt Bone Void Filler Device. |
| CFR Regulation Number | 888.3045 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VIVORTE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Shelf Life Exceeded | 2 |
Inaudible Or Unclear Audible Prompt / Feedback | 1 |
Device Handling Problem | 1 |
Shipping Damage Or Problem | 1 |
Use Of Device Problem | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corp. | II | Jun-25-2014 |
| 2 | Medtronic Sofamor Danek USA Inc | II | Feb-12-2014 |
| 3 | Musculoskeletal Transplant Foundation, Inc. | II | Jun-16-2016 |