The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Crossroads Screw System.
Device ID | K152072 |
510k Number | K152072 |
Device Name: | CrossRoads Screw System |
Classification | Screw, Fixation, Bone |
Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy Suite 140 Memphis, TN 38119 |
Contact | Vernon Hartgegen |
Correspondent | Vernon Hartdegen CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy Suite 140 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 | 2015-07-27 |
Decision Date | 2015-09-23 |
Summary: | summary |