Medical Device Manufacturer · US , Lweisville , TX

Orthofix - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2012

Recent clearances: FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM, CONSTRUX MINI PEEK TI SPACER SYSTEM

View 3 510(k) Devices ↓
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Orthofix Orthopedic ✕

3 devices
1-3 of 3
Cleared Mar 28, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176 · NKB
Orthopedic · 62d
Cleared Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901 · NKB
Orthopedic · 73d
Cleared Nov 29, 2012
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649 · ODP
Orthopedic · 177d
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