The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic Intramedullary Nail System.
| Device ID | K150655 |
| 510k Number | K150655 |
| Device Name: | OIC Intramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOPAEDIC IMPLANT COMPANY 316 CALIFORNIA AVE #701 Reno, NV 89509 |
| Contact | Douglas Fulton |
| Correspondent | Douglas Fulton ORTHOPAEDIC IMPLANT COMPANY 316 CALIFORNIA AVE #701 Reno, NV 89509 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-13 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20811998036599 | K150655 | 000 |
| 10811998036578 | K150655 | 000 |
| 10811998036011 | K150655 | 000 |
| 10811998036004 | K150655 | 000 |
| 10811998038145 | K150655 | 000 |
| M69601IM520 | K150655 | 000 |
| M69601IM010 | K150655 | 000 |
| 10811998036028 | K150655 | 000 |
| 10811998038169 | K150655 | 000 |
| 10811998038152 | K150655 | 000 |
| M696GW031000S0 | K150655 | 000 |
| 10811998036851 | K150655 | 000 |
| 10811998036585 | K150655 | 000 |
| M69601ARFN0010 | K150655 | 000 |
| M69601IM000 | K150655 | 000 |
| M69601IM480 | K150655 | 000 |
| 10811998036462 | K150655 | 000 |
| 10811998038084 | K150655 | 000 |
| 10811998038138 | K150655 | 000 |
| 10811998038121 | K150655 | 000 |
| 10811998038114 | K150655 | 000 |
| 10811998038107 | K150655 | 000 |
| 10811998038091 | K150655 | 000 |
| M69601TIB010 | K150655 | 000 |
| M69601IM550 | K150655 | 000 |
| M69601IM540 | K150655 | 000 |
| 10811998036844 | K150655 | 000 |