The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic External Fixation System.
| Device ID | K211112 |
| 510k Number | K211112 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-14 |
| Decision Date | 2021-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795114839 | K211112 | 000 |
| 00889795114679 | K211112 | 000 |
| 00889795114662 | K211112 | 000 |
| 00889795114655 | K211112 | 000 |
| 00889795114648 | K211112 | 000 |
| 00889795114631 | K211112 | 000 |
| 00889795114624 | K211112 | 000 |
| 00889795114617 | K211112 | 000 |
| 00889795114600 | K211112 | 000 |
| 00889795114594 | K211112 | 000 |
| 00889795114587 | K211112 | 000 |
| 00889795114570 | K211112 | 000 |
| 00889795114563 | K211112 | 000 |
| 00889795114686 | K211112 | 000 |
| 00889795114693 | K211112 | 000 |
| 00889795114709 | K211112 | 000 |
| 00889795114822 | K211112 | 000 |
| 00889795114815 | K211112 | 000 |
| 00889795114808 | K211112 | 000 |
| 00889795114792 | K211112 | 000 |
| 00889795114785 | K211112 | 000 |
| 00889795114778 | K211112 | 000 |
| 00889795114761 | K211112 | 000 |
| 00889795114754 | K211112 | 000 |
| 00889795114747 | K211112 | 000 |
| 00889795114730 | K211112 | 000 |
| 00889795114723 | K211112 | 000 |
| 00889795114716 | K211112 | 000 |
| 00889795114556 | K211112 | 000 |