| Device Type ID | 5941 |
| Device Name | Wax, Bone |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MTJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5941 |
| Device | Wax, Bone |
| Product Code | MTJ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HEMOSTASIS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOCON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ORTHOCON, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Adhere Or Bond | 11 |
Loss Of Or Failure To Bond | 6 |
Appropriate Term/Code Not Available | 6 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Material Fragmentation | 4 |
Incomplete Or Missing Packaging | 2 |
Device Markings / Labelling Problem | 2 |
Component Missing | 2 |
Chemical Problem | 1 |
Product Quality Problem | 1 |
Material Integrity Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operates Differently Than Expected | 1 |
Fluid Leak | 1 |
Packaging Problem | 1 |
Device Packaging Compromised | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Adhesive | 1 |
| Total Device Problems | 47 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes, Inc. | II | Feb-11-2015 |