The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic Variable Angle Small Fragment Locking Plate System.
| Device ID | K140357 |
| 510k Number | K140357 |
| Device Name: | OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-12 |
| Decision Date | 2014-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811998039845 | K140357 | 000 |
| M696014150 | K140357 | 000 |
| M69601ANK010 | K140357 | 000 |
| M69601CP010 | K140357 | 000 |
| M69601CP020 | K140357 | 000 |
| M69601DRP030 | K140357 | 000 |
| M69601DRP040 | K140357 | 000 |
| M69601FIB010 | K140357 | 000 |
| M69601PHP030 | K140357 | 000 |
| M69601PHP040 | K140357 | 000 |
| M69601PRXTIB010 | K140357 | 000 |
| M69601SF000 | K140357 | 000 |
| M696DR0010 | K140357 | 000 |
| 10811998035403 | K140357 | 000 |
| 10811998035410 | K140357 | 000 |
| 10811998033362 | K140357 | 000 |
| 10811998033355 | K140357 | 000 |
| 10811998033348 | K140357 | 000 |
| 10811998039852 | K140357 | 000 |
| 10811998031924 | K140357 | 000 |
| 10811998034116 | K140357 | 000 |
| 10811998034123 | K140357 | 000 |
| 10811998034130 | K140357 | 000 |
| 10811998033416 | K140357 | 000 |
| 10811998033423 | K140357 | 000 |
| 10811998033430 | K140357 | 000 |
| M69601SF050 | K140357 | 000 |
| M69601SF060 | K140357 | 000 |
| M69601SF070 | K140357 | 000 |
| 10811998033256 | K140357 | 000 |
| 10811998033263 | K140357 | 000 |
| 10811998033317 | K140357 | 000 |
| 10811998035427 | K140357 | 000 |
| 10811998035434 | K140357 | 000 |
| 10811998033973 | K140357 | 000 |
| 10811998033980 | K140357 | 000 |
| 10811998033997 | K140357 | 000 |
| 10811998034147 | K140357 | 000 |
| 10811998034154 | K140357 | 000 |
| M696DG18180 | K140357 | 000 |
| M696DG28280 | K140357 | 000 |
| M696DG28350 | K140357 | 000 |
| M696LG00180 | K140357 | 000 |
| M696LG00280 | K140357 | 000 |
| 10811998033386 | K140357 | 000 |
| M69601SF020 | K140357 | 000 |
| 20811998034113 | K140357 | 000 |
| 20811998034120 | K140357 | 000 |
| M69601SF130 | K140357 | 000 |
| 10811998033492 | K140357 | 000 |
| 10811998035533 | K140357 | 000 |
| 10811998035441 | K140357 | 000 |
| 10811998035458 | K140357 | 000 |
| 10811998035465 | K140357 | 000 |
| 10811998035472 | K140357 | 000 |
| 10811998035489 | K140357 | 000 |
| 10811998035496 | K140357 | 000 |
| 10811998035502 | K140357 | 000 |
| 10811998035519 | K140357 | 000 |
| 10811998035526 | K140357 | 000 |
| 10811998035540 | K140357 | 000 |
| 10811998035557 | K140357 | 000 |
| 10811998035564 | K140357 | 000 |
| 10811998035571 | K140357 | 000 |
| 10811998039487 | K140357 | 000 |
| 20811998034137 | K140357 | 000 |