The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Tl-hex True Lok Hexalobe System (tl-hex).
| Device ID | K141078 |
| 510k Number | K141078 |
| Device Name: | ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORTHOFIX SRL PO BOX 15729 Wilmington, NC 28408 |
| Contact | Cheryl Wagoner |
| Correspondent | Cheryl Wagoner ORTHOFIX SRL PO BOX 15729 Wilmington, NC 28408 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-25 |
| Decision Date | 2014-09-02 |
| Summary: | summary |