FDA Product Code
FDA Product Code MNH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 309 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071890 | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K070530 | MODIFICATION TO PASSMED SPINAL SYSTEM | Medicrea Technologies | 2007-10-18 | Special | PDF ↗ |
| K072282 | CAPLESS LI PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2007-09-14 | Special | PDF ↗ |
| K070933 | LOWTOP PEDICLE SCREW SYSTEM | Sanacor | 2007-06-13 | Traditional | PDF ↗ |
| K062670 | VERTIFLEX SPINAL SCREW SYSTEM | Vertiflex (Tm), Incorporated | 2007-01-12 | Traditional | PDF ↗ |
| K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2006-11-02 | Special | PDF ↗ |
| K061524 | ISS INTEGRATED SPINE SYSTEM | Ortho Development Corp. | 2006-09-26 | Traditional | PDF ↗ |
| K061813 | MANTIS SPINAL SYSTEM | Stryker Spine | 2006-09-19 | Traditional | PDF ↗ |
| K061577 | OVALTWIST PEDICLE SCREW SYSTEM | Signus Medizintechnik GmbH | 2006-09-14 | Traditional | PDF ↗ |
| K062196 | SFX SNAP-FIT CROSS CONNECTOR | Depuy Spine, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K061364 | PILOT POSTERIOR LUMBAR PLATING SYSTEM | Life Spine | 2006-09-05 | Traditional | PDF ↗ |
| K062317 | MODIFICATION TO NUVASIVE SPHERX II SYSTEM | Nuvasive, Inc. | 2006-09-01 | Special | PDF ↗ |
| K061162 | BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 | Applied Spine Technologies, Inc. | 2006-07-26 | Traditional | PDF ↗ |
| K061915 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-07-25 | Special | PDF ↗ |
| K061441 | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM | Ebi, L.P. | 2006-07-25 | Traditional | PDF ↗ |
| K061778 | NUVASIVE SPHERX II SYSTEM | Nuvasive, Inc. | 2006-07-18 | Special | PDF ↗ |
| K053623 | NFIX FUSION SYSTEM | N-Spine, Inc. | 2006-07-12 | Traditional | PDF ↗ |
| K061321 | ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX | Alphatec Spine, Inc. | 2006-07-07 | Special | PDF ↗ |
| K060702 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2006-06-22 | Traditional | PDF ↗ |
| K060118 | SSP PEDICLE SCREW SYSTEM | Specialty Spine Products, LLC | 2006-06-08 | Traditional | PDF ↗ |
| K060225 | NUVASIVE SPHERX SYSTEM | Nuvasive, Inc. | 2006-04-12 | Special | PDF ↗ |
| K053573 | GSS PEDICLE SCREW SYSTEM | GS Medical Co., Ltd. | 2006-03-08 | Traditional | PDF ↗ |
| K053070 | CONTOUR II SPINAL SYSTEM | Altiva Corp. | 2006-02-13 | Traditional | PDF ↗ |
| K051089 | GII SPINAL FIXATION SYSTEM | Co-Ligne AG | 2005-10-26 | Traditional | PDF ↗ |
| K051959 | NV CORMED SOLAS SPINAL SYSTEM | Nv Cormed | 2005-10-12 | Traditional | PDF ↗ |
| K051044 | ARCTEC SEMIRIGID PLATING SYSTEM | Altiva Corp. | 2005-10-07 | Traditional | PDF ↗ |
| K051697 | SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM | Medical Device Advisory Development Group | 2005-09-21 | Traditional | PDF ↗ |
| K050461 | XIA 4.5 SPINAL SYSTEM | Stryker Spine | 2005-07-27 | Traditional | PDF ↗ |
| K051216 | HYDRALOK SYSTEM | Altiva Corp. | 2005-07-19 | Traditional | PDF ↗ |
| K051286 | ZODIAC SPINAL FIXATION SYSTEM | Alphatec/Nexmed | 2005-06-17 | Special | PDF ↗ |
| K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2005-05-12 | Traditional | PDF ↗ |
| K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM | Solco Biomedical Co., Ltd. | 2005-03-07 | Traditional | PDF ↗ |
| K043180 | STRYKER SPINE TRIO PS | Stryker Spine | 2005-03-02 | Traditional | PDF ↗ |
| K050078 | ROC LUMBAR PLATING SYSTEM | Alphatec/Nexmed | 2005-02-18 | Traditional | PDF ↗ |
| K042928 | MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM | U&I Corp. | 2005-02-17 | Special | PDF ↗ |
| K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2005-02-01 | Special | PDF ↗ |
| K043343 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-12-28 | Special | PDF ↗ |
| K043001 | MX POLYAXIAL PEDICLE SCREW | Scient'X | 2004-12-01 | Special | PDF ↗ |
| K042640 | UNI-THREAD SPINAL SYSTEM | Spine Vision, Inc. | 2004-11-23 | Traditional | PDF ↗ |
| K042964 | MX MONOAXIAL PEDICLE SCREW | Scient'X | 2004-11-22 | Special | PDF ↗ |
| K040747 | ALADYN RIGID SPINE PLATE | Scient'X | 2004-06-17 | Special | PDF ↗ |
| K033512 | PROCYON SPINAL SYSTEM | Nas Medical Technologies, Inc. | 2004-06-03 | Traditional | PDF ↗ |
| K040442 | PROTEX STABILIZATION SYSTEM | Globus Medical, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K034056 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-04-21 | Special | PDF ↗ |
| K033546 | NUVASIVE SPINAL SYSTEM | Nuvasive, Inc. | 2004-04-12 | Traditional | PDF ↗ |
| K040072 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-02-12 | Special | PDF ↗ |
| K032604 | GII SPINAL FIXATION SYSTEM | Co-Ligne AG | 2004-01-20 | Traditional | PDF ↗ |
| K033322 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-12-15 | Special | PDF ↗ |
| K032855 | STRYKER SPINE MAPS SYSTEM | Howmedica Osteonics | 2003-12-10 | Traditional | PDF ↗ |
| K031265 | SHIRAZ-JAVA SPINAL FIXATION SYSTEM | Spine Next SA | 2003-10-09 | Traditional | PDF ↗ |
| K031585 | U&I, OPTIMA, SPINAL SYSTEM | U&I Corp., America | 2003-06-27 | Special | PDF ↗ |
| K023378 | ORIA CLARIS | Ortho Tec, LLC | 2003-06-27 | Traditional | PDF ↗ |
| K031423 | EBI P148 SPINAL FIXATION SYSTEM | Ebi, L.P. | 2003-06-27 | Traditional | PDF ↗ |
| K030581 | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) | Blackstone Medical, Inc. | 2003-06-26 | Special | PDF ↗ |
| K031290 | MODIFICATION TO EASYS TRANSVERSE CONNECTION | Scient'X USA, Inc. | 2003-05-13 | Special | PDF ↗ |
| K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS | Depuyacromed | 2003-02-26 | Special | PDF ↗ |
| K023994 | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ | Ortho Tec, LLC | 2003-02-05 | Special | PDF ↗ |
| K024348 | MONARCH SPINE SYSTEM | Depuyacromed | 2003-01-28 | Special | PDF ↗ |
| K020085 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X | Sintea Biotech, Inc. | 2002-12-10 | Traditional | PDF ↗ |
| K023438 | MODIFICATION TO MONARCH SPINE SYSTEM | Depuyacromed | 2002-11-13 | Special | PDF ↗ |
| K023204 | MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM | Ebi, L.P. | 2002-10-18 | Special | PDF ↗ |
| K021623 | UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS | Iame, Inc. | 2002-09-10 | Special | PDF ↗ |
| K021881 | ENDIUS TITLE SPINAL FIXATION SYSTEM | Endius, Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Alphatec Mfg., Inc. | 2002-07-23 | Traditional | PDF ↗ |
| K020247 | COLORADO 2 SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-07-22 | Traditional | PDF ↗ |
| K021335 | MONARCH SPINE SYSTEM | Depuyacromed | 2002-07-11 | Traditional | PDF ↗ |
| K021879 | CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) | Depuyacromed | 2002-06-26 | Special | PDF ↗ |
| K021880 | CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) | Depuyacromed | 2002-06-26 | Special | PDF ↗ |
| K013962 | EQUATION FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-06-20 | Traditional | PDF ↗ |
| K020699 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-05-28 | Traditional | PDF ↗ |
| K021148 | MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD | Depuyacromed | 2002-05-08 | Special | PDF ↗ |
| K020674 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW | Blackstone Medical, Inc. | 2002-04-03 | Traditional | PDF ↗ |
| K020681 | EBI OMEGA21 SPINAL FIXATION SYSTEM | Ebi, L.P. | 2002-04-03 | Special | PDF ↗ |
| K014302 | UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM | Pisharodi Surgicals, Inc. | 2002-03-29 | Traditional | PDF ↗ |
| K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | Sulzer Spine-Tech | 2002-02-15 | Special | PDF ↗ |
| K020293 | OSTEONICS SPINAL SYSTEM | Howmedica Osteonics Corp. | 2002-02-14 | Special | PDF ↗ |
| K013887 | BACFIX SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K020245 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | 2002-02-01 | Special | PDF ↗ |
| K014229 | MODIFICATION TO OPUS SPINAL SYSTEM | Howmedica Osteonics Corp. | 2002-01-25 | Special | PDF ↗ |
| K014137 | MODIFICATION TO EBI OMEGA 21 SYSTEM | Ebi, L.P. | 2002-01-16 | Special | PDF ↗ |
| K014076 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-12-27 | Special | PDF ↗ |
| K013688 | MODIFICATION TO XIA SPINAL SYSTEM | Howmedica Osteonics Corp. | 2001-12-05 | Special | PDF ↗ |
| K013444 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | 2001-11-16 | Special | PDF ↗ |
| K013296 | MOSS MIAMI SPINAL SYSTEMS | Depuyacromed | 2001-10-09 | Special | PDF ↗ |
| K013295 | TIMX SPINAL SYSTEMS | Depuyacromed | 2001-10-09 | Special | PDF ↗ |
| K013294 | MONARCH SPINAL SYSTEMS | Depuyacromed | 2001-10-09 | Special | PDF ↗ |
| K012971 | ISOLA SPINAL SYSTEMS | Depuyacromed | 2001-10-05 | Special | PDF ↗ |
| K012273 | SPIRAL RADIUS 90-D SST SYSTEM | United States Surgical, A Division of Tyco Healthc | 2001-08-15 | Special | PDF ↗ |
| K012027 | MODIFICATION TO XIA SPINE SYSTEM | Howmedica Osteonics | 2001-07-20 | Special | PDF ↗ |
| K003733 | SCS CLOSED SCREW | Ortho Tec, LLC | 2001-05-29 | Traditional | PDF ↗ |
| K011182 | MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS | Depuyacromed | 2001-05-16 | Special | PDF ↗ |
| K010369 | CLARIS PLATE SYSTEM | Ortho Tec, LLC | 2001-05-08 | Traditional | PDF ↗ |
| K010845 | MODIFICATION TO OSTEONICS SPINAL SYSTEM | Howmedica Osteonics Corp. | 2001-04-18 | Special | PDF ↗ |
| K010742 | MOSS MIAMI 5.5MM TITANIUM PIN NUT | Depuyacromed | 2001-04-12 | Special | PDF ↗ |
| K010720 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-04-11 | Special | PDF ↗ |
| K003463 | SOCON SPINAL SYSTEM | Aesculap, Inc. | 2001-04-11 | Special | PDF ↗ |
| K010776 | TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS | Corin USA | 2001-04-06 | Special | PDF ↗ |
| K010535 | TRIFIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-03-19 | Special | PDF ↗ |
| K010249 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-02-23 | Special | PDF ↗ |
| K003764 | MODIFICATION TO EBI SPINELINK SYSTEM | Ebi, L.P. | 2001-01-02 | Special | PDF ↗ |
Product code MNH · Class II · Orthopedic. Data: openFDA.