The following data is part of a premarket notification filed by Orthodiscovery Group Llc(d.b.a. Crossroads Extremity Systems with the FDA for Crossclip Implant System.
| Device ID | K142727 |
| 510k Number | K142727 |
| Device Name: | CrossCLIP Implant System |
| Classification | Staple, Fixation, Bone |
| Applicant | OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems 458 DISTRIBUTION PKWY Collierville, TN 38017 |
| Contact | Vernon Hartdegen |
| Correspondent | Vernon Hartdegen OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems 458 DISTRIBUTION PKWY Collierville, TN 38017 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-23 |
| Decision Date | 2014-10-24 |
| Summary: | summary |