The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Motoband¿ Cp Implant System.
Device ID | K152306 |
510k Number | K152306 |
Device Name: | MotoBand¿ 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 | 2015-08-14 |
Decision Date | 2015-12-11 |
Summary: | summary |