Medical Device Manufacturer · US , Austin , TX

Scien'Tx USA, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1999

Recent clearances: MODIFICATION TO ISOBAR SPINAL SYSTEM, ISOBAR SPINAL SYSTEM, ANTERIOR CERVICAL PLATE SYSTEM

View 8 510(k) Devices ↓
8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Scien'Tx USA, Inc. Orthopedic ✕

8 devices
1-8 of 8
Cleared Feb 01, 2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
K020245 · MNH
Orthopedic · 8d
Cleared Jan 15, 2002
ISOBAR SPINAL SYSTEM
K013447 · KWP
Orthopedic · 90d
Cleared Jan 14, 2002
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · KWQ
Orthopedic · 89d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Orthopedic · 30d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · MNI
Orthopedic · 203d
Cleared May 27, 1999
ISOLOCK SPINAL SYSTEM
K990721 · MNH
Orthopedic · 83d
Cleared Mar 22, 1999
ISOBAR SPINAL SYSTEM
K990118 · MNH
Orthopedic · 68d
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