Orthosis, Spondylolisthesis Spinal Fixation
FDA product code MNH · 287 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3070
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1995-01-20 – 2016-12-02
MNH
2006-02-13
MNH
2005-10-26
GII SPINAL FIXATION SYSTEM
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MNH
2005-10-12
NV CORMED SOLAS SPINAL SYSTEM
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MNH
2005-10-07
ARCTEC SEMIRIGID PLATING SYSTEM
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MNH
2005-09-21
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
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MNH
2005-07-27
XIA 4.5 SPINAL SYSTEM
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MNH
2005-07-19
HYDRALOK SYSTEM
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MNH
2005-06-17
ZODIAC SPINAL FIXATION SYSTEM
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MNH
2005-05-12
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
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MNH
2005-03-07
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
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MNH
2005-03-02
STRYKER SPINE TRIO PS
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MNH
2005-02-18
ROC LUMBAR PLATING SYSTEM
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MNH
2005-02-17
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
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MNH
2005-02-01
VERTEBRON PSS PEDICLE SCREW SYSTEM
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MNH
2004-12-28
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
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MNH
2004-12-01
MX POLYAXIAL PEDICLE SCREW
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MNH
2004-11-23
UNI-THREAD SPINAL SYSTEM
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MNH
2004-11-22
MX MONOAXIAL PEDICLE SCREW
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MNH
2004-06-17
ALADYN RIGID SPINE PLATE
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MNH
2004-06-03
PROCYON SPINAL SYSTEM
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MNH
2004-05-20
PROTEX STABILIZATION SYSTEM
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MNH
2004-04-21
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNH
2004-04-12
NUVASIVE SPINAL SYSTEM
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MNH
2004-02-12
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNH
2004-01-20
GII SPINAL FIXATION SYSTEM
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MNH
2003-12-15
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNH
2003-12-10
STRYKER SPINE MAPS SYSTEM
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MNH
2003-10-09
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
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MNH
2003-06-27
U&I, OPTIMA, SPINAL SYSTEM
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MNH
2003-06-27
EBI P148 SPINAL FIXATION SYSTEM
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MNH
2003-06-27
ORIA CLARIS
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MNH
2003-06-26
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
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MNH
2003-05-13
MODIFICATION TO EASYS TRANSVERSE CONNECTION
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MNH
2003-02-26
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
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MNH
2003-02-05
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
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MNH
2003-01-28
MONARCH SPINE SYSTEM
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MNH
2002-12-10
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
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MNH
2002-11-13
MODIFICATION TO MONARCH SPINE SYSTEM
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MNH
2002-10-18
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
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MNH
2002-09-10
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
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MNH
2002-07-29
ENDIUS TITLE SPINAL FIXATION SYSTEM
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MNH
2002-07-23
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
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MNH
2002-07-22
COLORADO 2 SPINAL SYSTEM
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MNH
2002-07-11
MONARCH SPINE SYSTEM
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MNH
2002-06-26
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
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MNH
2002-06-26
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
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MNH
2002-06-20
EQUATION FIXATION SYSTEM
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MNH
2002-05-28
TSRH SPINAL SYSTEM
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MNH
2002-05-08
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
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MNH
2002-04-03
EBI OMEGA21 SPINAL FIXATION SYSTEM
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MNH
2002-04-03
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
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MNH
2002-03-29
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
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MNH
2002-02-15
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
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MNH
2002-02-14
OSTEONICS SPINAL SYSTEM
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MNH
2002-02-12
BACFIX SPINAL FIXATION SYSTEM
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MNH
2002-02-01
MODIFICATION TO ISOBAR SPINAL SYSTEM
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MNH
2002-01-25
MODIFICATION TO OPUS SPINAL SYSTEM
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MNH
2002-01-16
MODIFICATION TO EBI OMEGA 21 SYSTEM
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MNH
2001-12-27
MODIFICATION TO TSRH SPINAL SYSTEM
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MNH
2001-12-05
MODIFICATION TO XIA SPINAL SYSTEM
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MNH
2001-11-16
ISOBAR SPINAL SYSTEM
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MNH
2001-10-09
MOSS MIAMI SPINAL SYSTEMS
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MNH
2001-10-09
TIMX SPINAL SYSTEMS
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MNH
2001-10-09
MONARCH SPINAL SYSTEMS
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MNH
2001-10-05
ISOLA SPINAL SYSTEMS
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MNH
2001-08-15
SPIRAL RADIUS 90-D SST SYSTEM
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MNH
2001-07-20
MODIFICATION TO XIA SPINE SYSTEM
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MNH
2001-05-29
SCS CLOSED SCREW
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MNH
2001-05-16
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
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MNH
2001-05-08
CLARIS PLATE SYSTEM
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MNH
2001-04-18
MODIFICATION TO OSTEONICS SPINAL SYSTEM
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MNH
2001-04-12
MOSS MIAMI 5.5MM TITANIUM PIN NUT
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MNH
2001-04-11
TSRH SPINAL SYSTEM
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MNH
2001-04-11
SOCON SPINAL SYSTEM
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MNH
2001-04-06
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
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MNH
2001-03-19
TRIFIX SPINAL FIXATION SYSTEM
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MNH
2001-02-23
CD HORIZON SPINAL SYSTEM
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MNH
2001-01-02
MODIFICATION TO EBI SPINELINK SYSTEM
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MNH
2000-12-22
CD HORIZON SPINAL SYSTEM
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MNH
2000-12-08
OPUS ROD FIXATION SYSTEM
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MNH
2000-11-24
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
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MNH
2000-11-03
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
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MNH
2000-10-19
GLOBAL SPINAL FIXATION SYSTEM
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MNH
2000-09-27
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNH
2000-07-11
CD HORIZON SPINAL SYSTEM
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MNH
2000-06-22
CD HORIZON ECLIPSE
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MNH
2000-06-03
TRIFIX SPINAL FIXATION SYSTEM
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MNH
2000-05-23
XIA SPINE SYSTEM HOOKS
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MNH
2000-05-23
PASS SPINAL SYSTEM
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MNH
2000-05-10
COLORADO II SPINAL SYSTEM
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MNH
2000-04-14
HAIDER-UCR SPINAL SYSTEM
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MNH
2000-04-10
5.0MM SPINAL SCREWS
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MNH
2000-03-30
COLORADO II SPINAL SYSTEM
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MNH
2000-03-10
MODIFICATION TO CD SPINAL SYSTEM
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MNH
2000-03-10
MODIFICATION TO CD SPINAL SYSTEM
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MNH
2000-02-28
BLACKSTONE SPINAL FIXATION SYSTEM
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MNH
2000-02-08
CLICK'X
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MNH
2000-02-08
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNH
2000-02-03
CD HORIZON SPINAL SYSTEM
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MNH
2000-02-03
MODIFICATION TO ISOBAR SPINAL SYSTEM
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