Medical Device Manufacturer · US , Palm Desert , CA

Alphatec Mfg., Inc. - FDA 510(k) Cleared Devices

20 submissions · 18 cleared · Since 1990
20
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alphatec Mfg., Inc. Orthopedic
20 devices
1-20 of 20
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · KWP
Orthopedic · 179d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · MNI
Orthopedic · 69d
Cleared Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356 · MNH
Orthopedic · 169d
Cleared Apr 26, 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · KWQ
Orthopedic · 191d
Cleared Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
K993873 · KTT
Orthopedic · 49d
Cleared Sep 22, 1999
PYLON INTRAMEDULLAARY NAIL SYSTEM
K992350 · HSB
Orthopedic · 70d
Cleared May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · JDW
Orthopedic · 81d
Cleared Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400 · KTT
Orthopedic · 175d
Cleared Feb 14, 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
K951846 · KWP
Orthopedic · 300d
Cleared Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · KTT
Orthopedic · 644d
Cleared Jun 29, 1994
ALPHA SPINAL SYSTEM
K930515 · KWP
Orthopedic · 513d
Cleared Feb 17, 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K933112 · HRS
Orthopedic · 237d
Cleared Apr 14, 1993
ALPHATEC 130 COMPRESSION HIP SCREW
K925500 · HRS
Orthopedic · 166d
Cleared Oct 09, 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256 · HWC
Orthopedic · 99d
Cleared Aug 06, 1992
ALPHATEC SMALL FRAGMENT SET
K922166 · HWC
Orthopedic · 90d
Cleared Aug 06, 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167 · HRS
Orthopedic · 90d
Cleared Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K922322 · HWC
Orthopedic · 79d
Cleared Jul 02, 1992
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622 · HRS
Orthopedic · 87d
Cleared Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
K914004 · HWC
Orthopedic · 90d
Cleared Sep 14, 1990
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959 · JEC
Orthopedic · 403d
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