The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Galaxy Wrist.
| Device ID | K141760 |
| 510k Number | K141760 |
| Device Name: | ORTHOFIX GALAXY WRIST |
| 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 | 2014-07-01 |
| Decision Date | 2014-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242515197 | K141760 | 000 |
| 18033509859618 | K141760 | 000 |
| 18054242511588 | K141760 | 000 |
| 18054242511595 | K141760 | 000 |
| 18054242511601 | K141760 | 000 |
| 18054242511618 | K141760 | 000 |
| 18054242511625 | K141760 | 000 |
| 18054242511632 | K141760 | 000 |
| 18054242511656 | K141760 | 000 |
| 18054242511663 | K141760 | 000 |
| 18054242511670 | K141760 | 000 |
| 18053340349857 | K141760 | 000 |