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 | K173710 |
510k Number | K173710 |
Device Name: | MotoBAND CP Implant System |
Classification | Screw, Fixation, Bone |
Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy Suite 140 Memphis, TN 38119 |
Contact | Chad Hollis |
Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-04 |
Decision Date | 2018-02-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815432026388 | K173710 | 000 |
00815432024773 | K173710 | 000 |
00815432025015 | K173710 | 000 |
00815432025039 | K173710 | 000 |
00815432025053 | K173710 | 000 |
00815432025114 | K173710 | 000 |
00815432025930 | K173710 | 000 |
00815432025947 | K173710 | 000 |
00815432025954 | K173710 | 000 |
00815432025961 | K173710 | 000 |
00815432025978 | K173710 | 000 |
00815432025985 | K173710 | 000 |
00815432026036 | K173710 | 000 |
00815432026050 | K173710 | 000 |
00815432026074 | K173710 | 000 |
00815432026098 | K173710 | 000 |
00815432026364 | K173710 | 000 |
00815432026371 | K173710 | 000 |
00815432024759 | K173710 | 000 |