Medical Device Manufacturer · US , Marietta , GA

Phalanx Innovations - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2016

Recent clearances: OsteoBullet Compression Screw, StarFuse Interphalangeal Pin

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Phalanx Innovations Orthopedic ✕

2 devices

1-2 of 2

Cleared Apr 29, 2016

OsteoBullet Compression Screw

Orthopedic · 85d

Cleared Apr 26, 2016

StarFuse Interphalangeal Pin

Orthopedic · 90d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 23, 2026