| Device Type ID | 1106 |
| Device Name | Screw, Fixation, Intraosseous |
| Regulation Description | Intraosseous Fixation Screw Or Wire. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.4880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DZL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1106 |
| Device | Screw, Fixation, Intraosseous |
| Product Code | DZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intraosseous Fixation Screw Or Wire. |
| CFR Regulation Number | 872.4880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAGER & MEISINGER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTRA-LOCK INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOBIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 124 |
Adverse Event Without Identified Device Or Use Problem | 43 |
Material Fragmentation | 27 |
Fracture | 15 |
Use Of Device Problem | 5 |
Migration Or Expulsion Of Device | 3 |
Difficult To Remove | 3 |
Bent | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Shaft | 2 |
Detachment Of Device Component | 2 |
Device-Device Incompatibility | 2 |
Unintended Movement | 2 |
Insufficient Information | 2 |
Device Or Device Fragments Location Unknown | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Material Deformation | 1 |
Screw Head | 1 |
Tip | 1 |
Screw | 1 |
Material Disintegration | 1 |
Material Twisted / Bent | 1 |
| Total Device Problems | 243 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Apr-05-2016 |