The following data is part of a premarket notification filed by Phalanx Innovations with the FDA for Starfuse Interphalangeal Pin.
| Device ID | K160194 |
| 510k Number | K160194 |
| Device Name: | StarFuse Interphalangeal Pin |
| Classification | Pin, Fixation, Smooth |
| Applicant | Phalanx Innovations 200 Cobb Pkw N, Bldg 200, Ste 210 Marietta, GA 30062 |
| Contact | Daniel Lanois |
| Correspondent | Cheryl Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-04-26 |
| Summary: | summary |