The following data is part of a premarket notification filed by Orthodiscovery Group Llc (d.b.a. Crossroads Extrem with the FDA for Crosstie Intraosseous Fixation System.
| Device ID | K141857 |
| 510k Number | K141857 |
| Device Name: | CrossTie Intraosseous Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville, TN 38017 |
| Contact | Vernon Hartdegen |
| Correspondent | Vernon Hartdegen ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM 458 DISTRIBUTION PKWY Collierville, TN 38017 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-10 |
| Decision Date | 2015-01-08 |
| Summary: | summary |