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 |
00815432026807 | K160300 | 000 |
00815432026791 | K160300 | 000 |
00815432026784 | K160300 | 000 |
00815432026777 | K160300 | 000 |
00815432026760 | K160300 | 000 |
00815432026630 | K160300 | 000 |
00815432026623 | K160300 | 000 |
00815432026616 | K160300 | 000 |
00815432025442 | K160300 | 000 |
00815432025435 | K160300 | 000 |
00815432025428 | K160300 | 000 |
00815432025411 | K160300 | 000 |
00815432025404 | K160300 | 000 |
00815432025398 | K160300 | 000 |
00815432025381 | K160300 | 000 |
00815432025374 | K160300 | 000 |
00815432026814 | K160300 | 000 |
00815432026821 | K160300 | 000 |
00815432026838 | K160300 | 000 |
00815432025206 | K160300 | 000 |
00815432025176 | K160300 | 000 |
00815432025169 | K160300 | 000 |
00815432025152 | K160300 | 000 |
00815432025145 | K160300 | 000 |
00815432025138 | K160300 | 000 |
00815432026609 | K160300 | 000 |
00815432026593 | K160300 | 000 |
00815432026586 | K160300 | 000 |
00815432026579 | K160300 | 000 |
00815432026562 | K160300 | 000 |
00815432026555 | K160300 | 000 |
00815432026548 | K160300 | 000 |
00815432026869 | K160300 | 000 |
00815432026852 | K160300 | 000 |
00815432026845 | K160300 | 000 |
00815432025367 | K160300 | 000 |