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 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 | Traditional | PDF ↗ |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 | Special | PDF ↗ |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 | Traditional | PDF ↗ |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 | Traditional | PDF ↗ |
| K162189 | ANAX 5.5 Spinal System | U&I Corporation | 2016-08-30 | Special | PDF ↗ |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 | Traditional | PDF ↗ |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 | Traditional | PDF ↗ |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 | Special | PDF ↗ |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 | Traditional | PDF ↗ |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 | Traditional | PDF ↗ |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 | Special | PDF ↗ |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 | Traditional | PDF ↗ |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 | Traditional | PDF ↗ |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 | Traditional | PDF ↗ |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 | Special | PDF ↗ |
| K142957 | Ideal pedicle screw spinal system | Jiangsu Ideal Medical Science & Technology Co., Ltd. | 2015-01-30 | Traditional | PDF ↗ |
| K142655 | CB PROT II Posterior Spinal System | Chin Bone Technique Corp | 2015-01-26 | Traditional | PDF ↗ |
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM | Valorem Surgical | 2015-01-07 | Traditional | PDF ↗ |
| K142290 | KangLi pedical screw spinal system | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-11-24 | Traditional | PDF ↗ |
| K134011 | GENERAL SPINAL SYSTEM | Changzhou Dean Medical Instrument Co, Ltd. | 2014-09-03 | Traditional | PDF ↗ |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | Spinevision S.A. | 2014-06-30 | Traditional | PDF ↗ |
| K140053 | KANGLI PEDICLE SCREW SPINAL SYSTEM | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-06-26 | Traditional | PDF ↗ |
| K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | Nexxt Spine, LLC | 2014-06-26 | Special | PDF ↗ |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | Kalitec Direct, LLC | 2014-06-19 | Traditional | PDF ↗ |
| K140787 | PLS (POSTERIOR LUMBAR SYSTEM) | Sintea Plustek, LLC | 2014-05-30 | Special | PDF ↗ |
| K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2014-05-20 | Special | PDF ↗ |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2014-05-14 | Special | PDF ↗ |
| K133690 | TRUE SPINAL FUSSION SYSTEM | Innovative Surgical Designs | 2014-05-07 | Traditional | PDF ↗ |
| K133287 | PRESSON SPINAL FIXATION SYSTEM | Nexus Spine, LLC | 2014-02-25 | Traditional | PDF ↗ |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | Spine Wave, Inc. | 2014-01-10 | Traditional | PDF ↗ |
| K132218 | PERFIX ILIAC SCREW SYSTEM | U&I Corporation | 2013-12-17 | Traditional | PDF ↗ |
| K132101 | ANAX 5.5 SPINAL SYSTEM | U&I Corporation | 2013-11-25 | Traditional | PDF ↗ |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | Osseus Fusion Systems, LLC | 2013-08-08 | Traditional | PDF ↗ |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | Captiva Spine | 2013-08-08 | Special | PDF ↗ |
| K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2013-05-31 | Traditional | PDF ↗ |
| K122994 | INTRAMEDULLARY NAIL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2013-04-12 | Traditional | PDF ↗ |
| K123487 | GSO GS1 CANNULATED SCREW SYSTEM | Gold Standard Orthopaedics, LLC | 2013-03-11 | Traditional | PDF ↗ |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2013-02-15 | Traditional | PDF ↗ |
| K123476 | MEGA 5.5 SPINE SYSTEM | Lsk Biopartners, Inc. | 2013-01-08 | Traditional | PDF ↗ |
| K122592 | INSTINCT JAVA SYSTEM | Zimmer Spine | 2013-01-04 | Traditional | PDF ↗ |
| K122814 | GALLEON PEDICLE SCREW SYSTEM | Everest Spine, LLC | 2012-12-03 | Traditional | PDF ↗ |
| K120832 | FORTEX PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2012-10-23 | Special | PDF ↗ |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | Ldr Spine USA, Inc. | 2012-06-27 | Special | PDF ↗ |
| K121016 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2012-06-27 | Special | PDF ↗ |
| K111940 | S 100 PEDICLE SCREW SYSTEM | Renovis Surgical Technologies, LLC | 2012-05-15 | Special | PDF ↗ |
| K120491 | DSS STABILIZATION SYSTEM-RIGID | Paradigm Spine, LLC | 2012-05-09 | Traditional | PDF ↗ |
| K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM | Bm Korea Co., Ltd. | 2012-05-09 | Traditional | PDF ↗ |
| K103573 | ARTS2 SPINAL FIXATION SYSTEM | Advanced Medical Technologies | 2011-12-28 | Traditional | PDF ↗ |
| K110633 | LANCER PEDICLE SCREW SYSTEM | Spinal Solutions, LLC | 2011-12-15 | Special | PDF ↗ |
| K111995 | XINGTM SPINE SYSTEM | Implanova Co., Ltd. | 2011-12-12 | Traditional | PDF ↗ |
| K111690 | DEVINE SPINAL SYSTEM | Changzhou Orthmed Medical Instrument Co., Ltd. | 2011-11-22 | Traditional | PDF ↗ |
| K110497 | PASS LP SPINAL SYSTEM | Medicrea International | 2011-09-26 | Special | PDF ↗ |
| K111370 | ODALYS PEDICLE SCREW SYSTEM | Kalitec Direct, LLC | 2011-09-21 | Traditional | PDF ↗ |
| K111362 | REXIOUS SPINAL FIXATION SYSTEM | Dio Medical Co., Ltd. | 2011-07-21 | Special | PDF ↗ |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2011-06-13 | Special | PDF ↗ |
| K110321 | TIGER SPINE SYSTEM | Corelink, LLC | 2011-05-25 | Traditional | PDF ↗ |
| K101374 | AAXTER A3 POSTERIOR SPINAL SYSTEM | Aaxter Co., Ltd. | 2011-03-16 | Traditional | PDF ↗ |
| K102574 | PALLA M SPINAL SYSTEM | Korea Bone Bank Co., Ltd. | 2011-03-07 | Traditional | PDF ↗ |
| K102636 | ZENITH PEDICLE SYSTEM | Apollo Spine, Inc. | 2011-03-03 | Traditional | PDF ↗ |
| K101818 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2011-02-11 | Traditional | PDF ↗ |
| K103085 | VENUS BASIC SPINAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2011-02-09 | Special | PDF ↗ |
| K102853 | FLAMENCO SPINAL FIXATION SYSTEM | Ulrich GmbH & Co. KG | 2011-01-25 | Traditional | PDF ↗ |
| K102870 | EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM | Exactech, Inc. | 2011-01-21 | Traditional | PDF ↗ |
| K101446 | EMERALD SPINAL SYSTEM | Mazor Surgical Technologies , Ltd. | 2011-01-20 | Traditional | PDF ↗ |
| K101278 | INERTIA PEDICLE SCREW SYSTEM | Nexxt Spine, LLC | 2010-12-20 | Special | PDF ↗ |
| K102488 | APEX SPINE SYSTEM W/ COCR RODS | Spinecraft, LLC | 2010-12-10 | Special | PDF ↗ |
| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | Pioneer Surgical Technology | 2010-08-10 | Traditional | PDF ↗ |
| K101678 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2010-07-28 | Special | PDF ↗ |
| K100706 | VENUS BASIC SPINAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2010-07-22 | Traditional | PDF ↗ |
| K100956 | SPONDY SPINAL FIXATION SYSTEM | Allure Spine LLC | 2010-07-09 | Traditional | PDF ↗ |
| K100373 | TYCHE PEDICLE SCREW SYSTEM | Kyung Won Medical Co., Ltd. | 2010-06-30 | Traditional | PDF ↗ |
| K100605 | MIS SYSTEM | Spine Wave, Inc. | 2010-06-04 | Traditional | PDF ↗ |
| K093670 | MODIFICATION TO: OASYS SYSTEM | Stryker Spine | 2010-03-18 | Special | PDF ↗ |
| K100122 | MODIFICATION TO CAPSURE PS SYSTEM | Spine Wave, Inc. | 2010-02-12 | Special | PDF ↗ |
| K091725 | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) | U&I Corp. | 2009-11-09 | Traditional | PDF ↗ |
| K092011 | NORM SPINAL SYSTEM | Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar | 2009-10-28 | Traditional | PDF ↗ |
| K083077 | ULC SPINAL PEDICLE SCREW SYSTEM | Otis Biotech Co., Ltd. | 2009-10-26 | Traditional | PDF ↗ |
| K083567 | GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW | Co-Ligne AG | 2009-09-14 | Special | PDF ↗ |
| K090224 | FORTEX PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2009-07-30 | Special | PDF ↗ |
| K090477 | ALPINE PEDICLE SCREW SYSTEM | Sanacor | 2009-07-27 | Traditional | PDF ↗ |
| K091110 | SPINAL EDGE TITAN PEDICLE SCREW SYSTEM | Spinal Edge, LLC | 2009-07-24 | Traditional | PDF ↗ |
| K090424 | DVX SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2009-05-14 | Traditional | PDF ↗ |
| K090228 | ROC LUMBAR PLATING SYSTEM | Alphatec Spine, Inc. | 2009-04-29 | Traditional | PDF ↗ |
| K083581 | LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2009-04-07 | Special | PDF ↗ |
| K080611 | MESA SPINAL SYSTEM | K2m, Inc. | 2009-03-04 | Special | PDF ↗ |
| K081153 | NOVEL SPINAL SYSTEM | Medyssey Co, Ltd. | 2009-01-30 | Traditional | PDF ↗ |
| K083826 | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM | Allez Spine, LLC | 2009-01-22 | Special | PDF ↗ |
| K081165 | ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2008-12-17 | Traditional | PDF ↗ |
| K082509 | EOS SPINAL SYSTEM | Korea Bone Bank Co., Ltd. | 2008-12-15 | Traditional | PDF ↗ |
| K082577 | PASS LP SPINAL SYSTEM | Medicrea Technologies | 2008-10-03 | Special | PDF ↗ |
| K081883 | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM | Us Spine | 2008-09-24 | Traditional | PDF ↗ |
| K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS | Solco Biomedical Co., Ltd. | 2008-09-23 | Special | PDF ↗ |
| K081331 | FIXXSURE CROSS LINK | Spineworks, LLC | 2008-07-23 | Traditional | PDF ↗ |
| K081631 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS | Sintea Biotech, Inc. | 2008-07-18 | Special | PDF ↗ |
| K081041 | GPS, G SURGICAL PEDICLE SYSTEM | G Surgical Co., Ltd. | 2008-06-27 | Traditional | PDF ↗ |
| K080828 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2008-06-27 | Special | PDF ↗ |
| K081381 | RANGE SPINAL SYSTEM, LARGE DENALI SCREWS | K2m, Inc. | 2008-06-13 | Special | PDF ↗ |
| K081296 | PREFERENCE PEDICLE SCREW SYSTEM | Us Spine | 2008-06-06 | Special | PDF ↗ |
| K080876 | DVX SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2008-06-04 | Traditional | PDF ↗ |
| K073531 | ACCIN PEDICLE SCREW SYSTEM | Accelerated Innovation, LLC | 2008-02-04 | Traditional | PDF ↗ |
Product code MNH · Class II · Orthopedic. Data: openFDA.