The following data is part of a premarket notification filed by Phalanx Innovations with the FDA for Osteobullet Compression Screw.
| Device ID | K160304 |
| 510k Number | K160304 |
| Device Name: | OsteoBullet Compression Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | Phalanx Innovations 200 Cobb Pkw N, Bldg 200, Ste 210 Marietta, GA 30062 |
| Contact | Daniel Lanois |
| Correspondent | Cheryl Wagoner Wagoner Consulting LLC P O Box 15729 Wilmington, NC 28408 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-04 |
| Decision Date | 2016-04-29 |
| Summary: | summary |