Medical Device Manufacturer · US , Sarasota , FL

Groupe Lepine - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

Recent clearances: EIS DYNAMIC MEMORY STAPLES SYSTEM, EIS THREADED SCREW FRACTURE FIXATION

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Groupe Lepine Orthopedic ✕

2 devices

1-2 of 2

Cleared Jan 10, 2000

EIS DYNAMIC MEMORY STAPLES SYSTEM

Orthopedic · 214d

Cleared Dec 20, 1999

EIS THREADED SCREW FRACTURE FIXATION

Orthopedic · 193d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 10, 2026