Alphatec Mfg., Inc. - FDA 510(k) Cleared Devices
Recent clearances: ICON POLYAXIAL PEDICLE SCREW SYSTEM, ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM, ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
20
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alphatec Mfg., Inc. Orthopedic ✕
20 devices
Cleared
Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
Orthopedic
179d
Cleared
Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
Orthopedic
69d
Cleared
Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
Orthopedic
169d
Cleared
Apr 26, 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
191d
Cleared
Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
Orthopedic
49d
Cleared
Sep 22, 1999
PYLON INTRAMEDULLAARY NAIL SYSTEM
Orthopedic
70d
Cleared
May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
Orthopedic
81d
Cleared
Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
Orthopedic
175d
Cleared
Feb 14, 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
Orthopedic
300d
Cleared
Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
Orthopedic
644d
Cleared
Jun 29, 1994
ALPHA SPINAL SYSTEM
Orthopedic
513d
Cleared
Feb 17, 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
Orthopedic
237d