The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Motoclip/himax Implant System.
| Device ID | K181410 |
| 510k Number | K181410 |
| Device Name: | MotoCLIP/HiMAX Implant System |
| Classification | Staple, Fixation, Bone |
| Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Parkway, Suite 140 Memphis, TN 38119 |
| Contact | Chad Hollis |
| Correspondent | Christine Seifert 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 | 2018-05-30 |
| Decision Date | 2018-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810112597622 | K181410 | 000 |
| 00810112597592 | K181410 | 000 |
| 00810112597585 | K181410 | 000 |