Definition: The Device Is Intended To Be Used As An Accessory Surrounding Orthopedic Pins And Wires During External Fixation Of Bones. The Sleeve Is Impregnated With Antibiotic (gentamicin) Which Is Released Over Time In Order To Inhibit Bacterial Colonization O
| Device Type ID | 4642 |
| Device Name | Accessory, System, External Fixator, Containing Antimicrobial Agent |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NJA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4642 |
| Device | Accessory, System, External Fixator, Containing Antimicrobial Agent |
| Product Code | NJA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| CFR Regulation Number | 888.3040 [🔎] |