Medical Device Manufacturer · US , Lawrenceville , NJ

Xtremi-T, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: REFIX INTERNAL FRACTURE FIXATION SCREWS, REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Xtremi-T, LLC Orthopedic ✕

2 devices

1-2 of 2

Cleared Sep 07, 2005

REFIX INTERNAL FRACTURE FIXATION SCREWS

Orthopedic · 204d

Cleared Apr 18, 2005

REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L

Orthopedic · 136d

Data Source

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

Last updated: Sep 25, 2026