The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Tl-hex True Lok Hexapod System (tl-hex) V1.4.
| Device ID | K152171 |
| 510k Number | K152171 |
| Device Name: | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORTHOFIX SRL VIA DELLE NAZIONI 9 Verona, IT 37012 |
| Contact | Gianluca Ricadona |
| Correspondent | Cheryl Wagoner WAGONER CONSULTING LLC 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 | 2015-08-04 |
| Decision Date | 2015-09-28 |
| Summary: | summary |