Product code MNH
- Device name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3070
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 |
| K142957 | Ideal pedicle screw spinal system | Jiangsu Ideal Medical Science & Technology Co., Ltd. | 2015-01-30 |
| K142655 | CB PROT II Posterior Spinal System | Chin Bone Technique Corp | 2015-01-26 |
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM | Valorem Surgical | 2015-01-07 |
| K142290 | KangLi pedical screw spinal system | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-11-24 |
| K134011 | GENERAL SPINAL SYSTEM | Changzhou Dean Medical Instrument Co, Ltd. | 2014-09-03 |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | Spinevision S.A. | 2014-06-30 |
| K140053 | KANGLI PEDICLE SCREW SPINAL SYSTEM | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-06-26 |
| K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | Nexxt Spine, LLC | 2014-06-26 |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | Kalitec Direct, LLC | 2014-06-19 |
| K140787 | PLS (POSTERIOR LUMBAR SYSTEM) | Sintea Plustek, LLC | 2014-05-30 |
| K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Spineart | 2014-05-20 |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2014-05-14 |
| K133690 | TRUE SPINAL FUSSION SYSTEM | Innovative Surgical Designs | 2014-05-07 |
| K133287 | PRESSON SPINAL FIXATION SYSTEM | Nexus Spine, LLC | 2014-02-25 |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | Spine Wave, Inc. | 2014-01-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841732169289 | PICASSO MIS Spinal System | CTL Medical Corporation | 2026-07-24 |
| 00841732169296 | PICASSO MIS Spinal System | CTL Medical Corporation | 2026-07-24 |
| 00841732169302 | PICASSO MIS Spinal System | CTL Medical Corporation | 2026-07-24 |
| 00841732169319 | PICASSO MIS Spinal System | CTL Medical Corporation | 2026-07-24 |
| 00841732169272 | PICASSO MIS Spinal System | CTL Medical Corporation | 2026-07-24 |
| 07290115932508 | Tower Guide ST | PREMIA SPINE LTD | 2026-07-23 |
| 00812352020076 | Royal Oak Pedicle Screw System | ROMD, LLC | 2015-10-21 |
| 00812352020199 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020298 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020205 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020212 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020229 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020236 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020243 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020250 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020267 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020274 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020281 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020175 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020168 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020144 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020137 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020120 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020113 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020106 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020090 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020083 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020014 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020007 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-20 |
| 00812352020182 | Royal Oak Pedicle Screw System | ROMD, LLC | 2014-09-19 |