The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Motoclip/himax Step Staple Implant System.
| Device ID | K181866 |
| 510k Number | K181866 |
| Device Name: | MotoCLIP/HiMAX Step Staple Implant System |
| Classification | Staple, Fixation, Bone |
| Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy, Suite 140 Memphis, TN 38119 |
| Contact | Chad Hollis |
| Correspondent | Theresa Leister MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815432026517 | K181866 | 000 |
| 00815432026401 | K181866 | 000 |
| 00815432026418 | K181866 | 000 |
| 00815432026425 | K181866 | 000 |
| 00815432026432 | K181866 | 000 |
| 00815432026456 | K181866 | 000 |
| 00815432026463 | K181866 | 000 |
| 00815432026470 | K181866 | 000 |
| 00815432026487 | K181866 | 000 |
| 00815432026494 | K181866 | 000 |
| 00815432026395 | K181866 | 000 |