FDA Product Code
FDA Product Code MNI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 303 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 | Traditional | PDF ↗ |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 | Traditional | PDF ↗ |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 | Traditional | PDF ↗ |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 | Traditional | PDF ↗ |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 | Special | PDF ↗ |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 | Traditional | PDF ↗ |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 | Traditional | PDF ↗ |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 | Traditional | PDF ↗ |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 | Traditional | PDF ↗ |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 | Traditional | PDF ↗ |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 | Traditional | PDF ↗ |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 | Traditional | PDF ↗ |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 | Special | PDF ↗ |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 | Traditional | PDF ↗ |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 | Special | PDF ↗ |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 | Special | PDF ↗ |
| K150294 | DPZ Pedicular Fixation System | Osteomed Implantes, Ltda | 2015-06-05 | Traditional | PDF ↗ |
| K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | 2015-04-08 | Special | PDF ↗ |
| K150049 | PASS LP Spinal System | Medicrea International | 2015-02-10 | Special | PDF ↗ |
| K141253 | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM | New Era Orthopaedics, LLC | 2015-01-09 | Traditional | PDF ↗ |
| K140738 | PASS LP SPINAL SYSTEM | Medicrea International | 2014-11-04 | Traditional | PDF ↗ |
| K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS | Spineart | 2014-09-10 | Special | PDF ↗ |
| K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM | Precision Spine, Inc. | 2014-06-26 | Special | PDF ↗ |
| K132788 | MYSPINE PEDICLE SCREW PLACEMENT GUIDES | Medacta International | 2014-05-23 | Traditional | PDF ↗ |
| K140229 | GENERAL SPINAL SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2014-04-29 | Traditional | PDF ↗ |
| K133103 | AVERSION PEDICLE SCREW SYSTEM | K7, LLC | 2014-01-27 | Traditional | PDF ↗ |
| K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013-12-16 | Traditional | PDF ↗ |
| K132757 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-11-20 | Traditional | PDF ↗ |
| K132280 | ALTUS SPINE PEDICLE SCREW SYSTEM | Altus Partners | 2013-10-31 | Traditional | PDF ↗ |
| K130958 | TRUE SPINAL FIXATION SYSTEM | Innovative Surgical Designs | 2013-10-17 | Traditional | PDF ↗ |
| K132412 | INERTIA MIS PEDICLE SCREW SYSTEM | Nexxt Spine, LLC | 2013-10-10 | Special | PDF ↗ |
| K132361 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K132644 | LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU | Corentec Co., Ltd. | 2013-09-19 | Special | PDF ↗ |
| K132365 | SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION | Accel Spine | 2013-08-20 | Special | PDF ↗ |
| K131522 | CORE PEDICLE SCREW SYSTEM | Core-Nexus | 2013-08-09 | Traditional | PDF ↗ |
| K132154 | CAPSURE PS SYSTEM | Spine Wave, Inc. | 2013-08-09 | Special | PDF ↗ |
| K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT | Spinevision S.A. | 2013-07-30 | Special | PDF ↗ |
| K131343 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2013-07-24 | Traditional | PDF ↗ |
| K130279 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2013-06-20 | Traditional | PDF ↗ |
| K123521 | RELIANCE SPINAL SCREW SYSTEM | Reliance Medical Systems, LLC | 2013-02-07 | Special | PDF ↗ |
| K122931 | S-LOK PSS SYSTEM | Spinal USA | 2012-11-20 | Traditional | PDF ↗ |
| K122163 | CERTEX SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2012-10-31 | Traditional | PDF ↗ |
| K122332 | TOWERLOX PEDICLE SCREW SYSTEM | Captiva Spine | 2012-10-16 | Special | PDF ↗ |
| K122233 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-10-11 | Special | PDF ↗ |
| K121615 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2012-08-15 | Special | PDF ↗ |
| K121172 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2012-08-08 | Special | PDF ↗ |
| K120646 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-06-07 | Traditional | PDF ↗ |
| K120899 | RANGE SPINAL SYSTEM, UNIT ROD | K2m, Inc. | 2012-05-25 | Special | PDF ↗ |
| K120879 | LEXUS CERVICAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2012-05-23 | Special | PDF ↗ |
| K120099 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2012-05-18 | Special | PDF ↗ |
| K112611 | SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS | Sintea Plastek, LLC | 2012-04-25 | Special | PDF ↗ |
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM | Captiva Spine, Inc. | 2012-04-13 | Special | PDF ↗ |
| K120656 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2012-04-04 | Special | PDF ↗ |
| K120696 | TIGER SPINE SYSTEM | Corelink, LLC | 2012-04-02 | Special | PDF ↗ |
| K120538 | PALLS M SPINAL SYSTEM | Korea Bone Bank Co., Ltd. | 2012-03-23 | Special | PDF ↗ |
| K113157 | AILERON INTERSPINOUS FIXATION SYSTEM | Life Spine | 2012-03-13 | Special | PDF ↗ |
| K113755 | SAVANNAH TECHNOLOGIES SPINAL SYSTEM | Savannah Technologies, LLC | 2012-02-01 | Traditional | PDF ↗ |
| K113149 | SYNTHES USS CONNECTORS | Synthes Spine | 2012-02-01 | Traditional | PDF ↗ |
| K110896 | RELIANCE SPINAL SCREW SYSTEM | Reliance Medical Systems, LLC | 2012-01-20 | Special | PDF ↗ |
| K112920 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2011-12-21 | Special | PDF ↗ |
| K112484 | ZAVATION SPINAL SYSTEM | Zavation, LLC | 2011-11-22 | Traditional | PDF ↗ |
| K112493 | PASS LP SPINAL SYSTEM | Medicrea International | 2011-11-21 | Special | PDF ↗ |
| K111883 | SMARTLOC SPINAL FIXATION SYSTEM | A-Spine Asia, Co., Ltd. | 2011-10-18 | Traditional | PDF ↗ |
| K112037 | RANGE SPINAL SYSTEM (MESA AND DENALI) | K2m, Inc. | 2011-10-06 | Special | PDF ↗ |
| K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | Captiva Spine, Inc. | 2011-09-13 | Special | PDF ↗ |
| K111913 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2011-08-31 | Special | PDF ↗ |
| K112108 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2011-08-19 | Special | PDF ↗ |
| K111127 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2011-08-11 | Special | PDF ↗ |
| K110991 | MESA SPINAL SYSTEM (KEYSTONE RODS) | K2m, Inc. | 2011-08-02 | Special | PDF ↗ |
| K103414 | VENUS CERVICAL SPINAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2011-07-22 | Traditional | PDF ↗ |
| K110197 | EXACTECH GIBRALT SPINAL SYSTEM | Exactech, Inc. | 2011-07-15 | Traditional | PDF ↗ |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Medyssey Co, Ltd. | 2011-06-08 | Special | PDF ↗ |
| K110283 | ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2011-05-19 | Special | PDF ↗ |
| K103440 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2011-03-17 | Traditional | PDF ↗ |
| K103102 | LEUCADIA PEDICLE SCREW SYSTEM | Phygen, LLC | 2011-02-08 | Special | PDF ↗ |
| K102995 | TALON SPINAL SYSTEM | Spine360 | 2011-02-02 | Special | PDF ↗ |
| K103272 | ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2010-12-29 | Special | PDF ↗ |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Medyssey Co, Ltd. | 2010-12-16 | Special | PDF ↗ |
| K101682 | S 100 PEDICLE SCREW SYSTEM | Renovis Surgical Technologies, LLC | 2010-12-07 | Traditional | PDF ↗ |
| K103100 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2010-11-17 | Special | PDF ↗ |
| K100407 | LIFE SPINE INTERSPINOUS FIXATION SYSTEM | Life Spine | 2010-11-05 | Traditional | PDF ↗ |
| K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | Ldr Spine USA | 2010-10-15 | Special | PDF ↗ |
| K093833 | KAPSS SPINAL SYSTEM | Robert Reid, Inc. | 2010-10-15 | Traditional | PDF ↗ |
| K100851 | RANGE SPINAL SYSTEM | K2m, Inc. | 2010-08-02 | Traditional | PDF ↗ |
| K100765 | FIXPINE II SYSTEM | Dio Medical Co., Ltd. | 2010-07-19 | Traditional | PDF ↗ |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2010-06-25 | Traditional | PDF ↗ |
| K100377 | DIAMONDBACK SPINAL SYSTEM | Eminent Spine | 2010-04-22 | Traditional | PDF ↗ |
| K092076 | AEGIS & AEGIS II SPINAL SYSTEM | Corentec Co., Ltd. | 2010-04-02 | Traditional | PDF ↗ |
| K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | Ldr Spine USA | 2010-03-31 | Special | PDF ↗ |
| K093936 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2010-03-11 | Special | PDF ↗ |
| K100297 | PASS LP SPINAL SYSTEM | Medicrea Technologies | 2010-03-04 | Traditional | PDF ↗ |
| K100138 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2010-02-17 | Special | PDF ↗ |
| K093077 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2009-12-23 | Special | PDF ↗ |
| K093285 | MODIFICATION TO LANX SPINAL FIXATION SYSTEM | Lanx, LLC | 2009-12-10 | Special | PDF ↗ |
| K092420 | KRD1 PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2009-11-19 | Traditional | PDF ↗ |
| K092640 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2009-11-06 | Special | PDF ↗ |
| K093170 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2009-11-04 | Special | PDF ↗ |
| K092128 | MODIFICATION TO: PSS SYSTEM | Spinal USA | 2009-09-14 | Special | PDF ↗ |
| K083810 | PASS LP SPINAL SYSTEM | Medicrea Technologies | 2009-07-31 | Special | PDF ↗ |
| K091189 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2009-07-08 | Special | PDF ↗ |
Product code MNI · Class II · Orthopedic. Data: openFDA.