The following data is part of a premarket notification filed by The Orthopaedic Implant Company with the FDA for Oic Intramedullary Nail System.
| Device ID | K181184 |
| 510k Number | K181184 |
| Device Name: | OIC Intramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | The Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Contact | Douglas Fulton |
| Correspondent | Douglas Fulton The Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-03 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811998036554 | K181184 | 000 |
| 10811998036530 | K181184 | 000 |
| 10811998036523 | K181184 | 000 |
| 10811998036509 | K181184 | 000 |