Orthosis, Spinal Pedicle Fixation
FDA product code MNI · 285 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
- 1998-03-20 – 2017-10-12
MNI
2003-06-27
MNI
2003-05-16
CD HORIZON SPINAL SYSTEM
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MNI
2003-05-15
MODIFICATION TO HORIZON SPINAL SYSTEM
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MNI
2003-04-17
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
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MNI
2003-03-24
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
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MNI
2003-03-12
OPTIMA, SPINAL SYSTEM
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MNI
2003-03-06
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
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MNI
2003-02-05
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
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MNI
2002-12-11
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
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MNI
2002-11-25
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
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MNI
2002-11-13
AMT POLYAXIAL PEDICLE SCREW
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MNI
2002-09-23
PLUS PIVOT LINK UNIVERSAL SYSTEM
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MNI
2002-09-18
MODIFICATION TO TSRH SPINAL SYSTEM
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MNI
2002-08-13
MODIFICATION TO ISOLA SPINAL SYSTEM
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MNI
2002-08-01
XIA SPINAL SYSTEM
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MNI
2002-08-01
UNI-T UNI-THREAD SPINAL SYSTEM
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MNI
2002-07-24
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
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MNI
2002-07-18
MICOMED POSTERIOR DOUBLEROD SYSTEM
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MNI
2002-06-20
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
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MNI
2002-05-31
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
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MNI
2002-05-03
MODIFICATION TO TSRH SPINAL SYSTEM
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MNI
2002-04-15
SYNTHES DUAL-OPENING USS
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MNI
2002-02-13
UNI-T SPINAL SYSTEM
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MNI
2002-02-01
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
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MNI
2001-11-16
ISOBAR SPINAL SYSTEM
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MNI
2001-11-15
PASS SPINAL SYSTEM
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MNI
2001-11-14
TRI-FIX SPINAL FIXATION SYSTEM
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MNI
2001-11-07
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
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MNI
2001-10-24
PASS SPINAL SYSTEM
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MNI
2001-08-07
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
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MNI
2001-07-31
PASS SPINAL SYSTEM
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MNI
2001-06-12
ISOLA BAND CLAMP
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MNI
2001-06-06
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
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MNI
2001-06-06
TRI-FIX SPINAL FIXATION SYSTEM
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MNI
2001-06-06
TRI-FIX SPINAL FIXATION SYSTEM
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MNI
2001-06-06
USS-LINE EXTENSION
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MNI
2001-06-05
MODIFICATION TO TSRH SPINAL SYSTEM
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MNI
2001-06-04
MODIFIED USS FRACTURE SYSTEM
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MNI
2001-05-25
END-TO-END AND SIDE-BY-SIDE CONNECTORS
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MNI
2001-05-23
MONARCH SPINE SYSTEM
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MNI
2001-05-08
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
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MNI
2001-05-04
MODIFICATION TO TSRH SPINAL SYSTEM
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MNI
2000-10-17
SMALL STATURE USS
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MNI
2000-06-01
TRI-FIX SPINAL FIXATION SYSTEM
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MNI
2000-05-11
MULTI-AXIAL CROSS (MAC) CONNECTOR
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MNI
2000-04-18
MODIFICATION TO TSRH SPINAL SYSTEM
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MNI
2000-04-18
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
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MNI
2000-04-14
MODIFICATION TO EBI SPINELINK SYSTEM
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MNI
2000-03-10
MODIFICATION TO SYNTHES USS
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MNI
2000-03-07
ISOBAR SPINAL SYSTEM
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MNI
2000-02-28
TRIPLE-FIX SPINAL FIXATION SYSTEM
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MNI
2000-02-16
SYNERGY VLS CAP NUT MODELS 2206, 6102
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MNI
2000-01-13
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
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MNI
1999-12-20
OPUS SPINAL SYSTEM
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MNI
1999-11-23
EBI SPINELINK SYSTEM
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MNI
1999-11-08
ISOBAR SPINAL SYSTEM
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MNI
1999-11-08
ISOBAR SEMI-RIGID SPINAL SYSTEM
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MNI
1999-10-13
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
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MNI
1999-10-08
EBI OMEGA 21 SYSTEM
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MNI
1999-10-01
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
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MNI
1999-09-21
CD HORIZON SPINAL SYSTEM
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MNI
1999-08-13
EBI OMEGA 21 SYSTEM
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MNI
1999-06-28
SYNERGY ADJUSTABLE LENGTH ROD
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MNI
1999-03-30
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
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MNI
1999-03-23
SYNERGY D2 SPINAL IMPLANTS
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MNI
1999-02-01
OSTEONICS COMBINATION SCREW RING/BLOCKER
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MNI
1999-01-28
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
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MNI
1999-01-20
VSP SYSTEM
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MNI
1999-01-20
TIMX LOW BACK SYSTEM
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MNI
1999-01-19
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
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MNI
1999-01-19
EBI SPINELINK SYSTEM
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MNI
1999-01-06
MODIFICATION OF TSRH SPINAL SYSTEM
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MNI
1998-12-30
DEPUY ACROMED MOSS SPINAL SYSTEM
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MNI
1998-12-18
CD SPINAL SYSTEM
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MNI
1998-12-16
DYNA-LOK SPINAL SYSTEM
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MNI
1998-10-21
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
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MNI
1998-10-21
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
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MNI
1998-10-21
TSRH SPINAL SYSTEM
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MNI
1998-10-21
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
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MNI
1998-10-21
ISOLA SPINAL SYSTEM
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MNI
1998-10-02
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
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MNI
1998-10-02
AESCULAP SPINE SYSTEM EVOLUTION
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MNI
1998-08-07
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
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MNI
1998-07-13
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
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MNI
1998-03-20
TOWNLEY PEDICLE SCREW PLATING SYSTEM
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