The following data is part of a premarket notification filed by Crossroads Extemity Systems, Llc with the FDA for Motoband Cp Implant System.
| Device ID | K193452 |
| 510k Number | K193452 |
| Device Name: | MotoBAND CP Implant System |
| Classification | Plate, Fixation, Bone |
| Applicant | CrossRoads Extemity Systems, LLC 6055 Primacy Pkwy, Suite 140 Memphis, TN 38119 |
| Contact | Kim Strohkirch |
| Correspondent | Kim Strohkirch CrossRoads Extemity Systems, LLC 6055 Primacy Pkwy, Suite 140 Memphis, TN 38119 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815432029747 | K193452 | 000 |
| 00815432029570 | K193452 | 000 |
| 00815432029563 | K193452 | 000 |
| 00815432029556 | K193452 | 000 |
| 00815432028863 | K193452 | 000 |