The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Motoband(tm) Cp Implant System.
| Device ID | K160300 |
| 510k Number | K160300 |
| Device Name: | MotoBand(TM) CP Implant System |
| Classification | Plate, Fixation, Bone |
| Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy Suite 140 Memphis, TN 38119 |
| Contact | Vernon Hartdegen |
| Correspondent | Vernon Hartdegen CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy Suite 140 Memphis, TN 38119 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-04 |
| Decision Date | 2016-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815432025237 | K160300 | 000 |
| 00815432025206 | K160300 | 000 |
| 00815432025176 | K160300 | 000 |
| 00815432025169 | K160300 | 000 |
| 00815432025152 | K160300 | 000 |
| 00815432025145 | K160300 | 000 |
| 00815432025138 | K160300 | 000 |