The following data is part of a premarket notification filed by Crossroads Extremity Systems, Llc with the FDA for Crossroads Tray System.
Device ID | K202268 |
510k Number | K202268 |
Device Name: | CrossRoads Tray System |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy, Suite 140 Memphis, TN 38119 |
Contact | Kim Strohkirch |
Correspondent | Kim Strohkirch CrossRoads Extremity Systems, LLC 6055 Primacy Pkwy, Suite 140 Memphis, TN 38119 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-11 |
Decision Date | 2020-12-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810112598094 | K202268 | 000 |
00810112597851 | K202268 | 000 |
00810112597615 | K202268 | 000 |