Product code MNI
- Device name
- Orthosis, Spinal Pedicle 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 |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 |
| K150294 | DPZ Pedicular Fixation System | Osteomed Implantes, Ltda | 2015-06-05 |
| K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | 2015-04-08 |
| K150049 | PASS LP Spinal System | Medicrea International | 2015-02-10 |
| K141253 | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM | New Era Orthopaedics, LLC | 2015-01-09 |
| K140738 | PASS LP SPINAL SYSTEM | Medicrea International | 2014-11-04 |
| K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS | Spineart | 2014-09-10 |
| K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM | Precision Spine, Inc. | 2014-06-26 |
| K132788 | MYSPINE PEDICLE SCREW PLACEMENT GUIDES | Medacta International | 2014-05-23 |
| K140229 | GENERAL SPINAL SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2014-04-29 |
| K133103 | AVERSION PEDICLE SCREW SYSTEM | K7, LLC | 2014-01-27 |
| K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2013-12-16 |
| K132757 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-11-20 |
| K132280 | ALTUS SPINE PEDICLE SCREW SYSTEM | Altus Partners | 2013-10-31 |
| K130958 | TRUE SPINAL FIXATION SYSTEM | Innovative Surgical Designs | 2013-10-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290115935905 | XL Screwdriver CM | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935912 | Screwdriver CM | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935929 | Tube for K-wire over a k-wire technique 470mm (Nitinol) | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935936 | Tube for XL K-Wire 450mm | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935943 | Tube for K-Wires of 470mm | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935950 | Tube for K-Wires up to 340mm | PREMIA SPINE LTD | 2026-10-20 |
| 07290115935677 | XL Adaptor | PREMIA SPINE LTD | 2026-10-20 |
| 07290115932874 | Cannulated Screwdriver inner shaft | PREMIA SPINE LTD | 2026-10-18 |
| 07290115932881 | Cannulated Screwdriver Handle Assy | PREMIA SPINE LTD | 2026-10-18 |
| M697X07382580DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382595DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382590DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382585DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382575DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382570DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382565DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07382560DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X073825100DL1 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| M697X07300251 | Xpress Minimally Invasive Pedicle Screw System | Xtant Medical Holdings, Inc. | 2026-10-14 |
| 00840916111465 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111472 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111489 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111496 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111502 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111526 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111533 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111540 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111557 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111564 | TALON | SPINAL ELEMENTS | 2017-07-10 |
| 00840916111571 | TALON | SPINAL ELEMENTS | 2017-07-10 |