The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic External Fixation System.
| Device ID | K183682 |
| 510k Number | K183682 |
| Device Name: | OIC External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Contact | Douglas Fulton |
| Correspondent | Douglas Fulton Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-04-08 |