The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic External Fixation System.
| Device ID | K171211 |
| 510k Number | K171211 |
| 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 | 2017-04-25 |
| Decision Date | 2017-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811998038268 | K171211 | 000 |
| M696BTHP0545M0 | K171211 | 000 |
| M696BTHP0555L0 | K171211 | 000 |
| M696BTHP0565L0 | K171211 | 000 |
| M696STHP04200 | K171211 | 000 |
| M696STHP04300 | K171211 | 000 |
| M696STHP0535M0 | K171211 | 000 |
| M696STHP0545M0 | K171211 | 000 |
| M696STHP0555L0 | K171211 | 000 |
| M696STHP0565L0 | K171211 | 000 |
| M696TFP052500 | K171211 | 000 |
| 10811998038350 | K171211 | 000 |
| 10811998038367 | K171211 | 000 |
| 10811998038374 | K171211 | 000 |
| M696BTHP0535M0 | K171211 | 000 |
| M696BTHP04300 | K171211 | 000 |
| 10811998038275 | K171211 | 000 |
| 10811998038282 | K171211 | 000 |
| 10811998038299 | K171211 | 000 |
| 10811998038305 | K171211 | 000 |
| 10811998038312 | K171211 | 000 |
| 10811998038398 | K171211 | 000 |
| 10811998038404 | K171211 | 000 |
| 10811998038411 | K171211 | 000 |
| 10811998038428 | K171211 | 000 |
| 10811998038435 | K171211 | 000 |
| 10811998038442 | K171211 | 000 |
| 10811998038459 | K171211 | 000 |
| M696BTHP04200 | K171211 | 000 |
| 10811998038381 | K171211 | 000 |
| 10811998038466 | K171211 | 000 |
| M696XBR111500 | K171211 | 000 |
| M696XBR112000 | K171211 | 000 |
| M696XBR112500 | K171211 | 000 |
| M696XBR113000 | K171211 | 000 |
| M696XBR113500 | K171211 | 000 |
| M696XBR114000 | K171211 | 000 |
| M696XBR114500 | K171211 | 000 |
| M696XBR115000 | K171211 | 000 |
| M696XBR115500 | K171211 | 000 |
| M696XBR116000 | K171211 | 000 |
| 10811998038206 | K171211 | 000 |
| M69601EXF000 | K171211 | 000 |
| 10811998038558 | K171211 | 000 |
| M696XBR111000 | K171211 | 000 |
| M696EXFP900 | K171211 | 000 |
| 10811998038473 | K171211 | 000 |
| 10811998038480 | K171211 | 000 |
| 10811998038497 | K171211 | 000 |
| 10811998038503 | K171211 | 000 |
| 10811998038510 | K171211 | 000 |
| 10811998038527 | K171211 | 000 |
| 10811998038534 | K171211 | 000 |
| 10811998038541 | K171211 | 000 |
| M696CAP05251 | K171211 | 000 |
| M696EXFC11050 | K171211 | 000 |
| M696EXFMC050 | K171211 | 000 |
| M696EXFP000 | K171211 | 000 |
| M696EXFP300 | K171211 | 000 |
| 20811998038326 | K171211 | 000 |