MNI — Orthosis, Spinal Pedicle Fixation Class II
FDA product code MNI covers "Orthosis, Spinal Pedicle Fixation", a Class II medical device regulated under 21 CFR 888.3070. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MNI
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171497 | Mikron Makina Sanayi Ticaret Co. | Mikron Spinal Fixation System | Oct 12, 2017 |
| K160731 | Cg Bio Co | LumFix Spinal Fixation Sytem | Oct 4, 2016 |
| K151458 | Double Medical Technology | Double Medical Universal Spine System | Aug 22, 2016 |
| K153273 | Medacta International | MySpine Pedicle Screw Placement Guides - LP | Jun 29, 2016 |
| K160124 | Spinevision | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation | Apr 4, 2016 |
| K160320 | Shandong Weigao Orthopaedic Device Co | Premier | Apr 1, 2016 |
| K160003 | Spine Wave | Sniper (R) Spine System | Feb 26, 2016 |
| K152324 | Beijing Weigao Yahua Artificial Joint Development Co. | YAHUA Spinal System | Feb 1, 2016 |
| K143222 | Mighty Oak Medical | FIREFLY Pedicle Screw Navigation Guide | Dec 11, 2015 |
| K150684 | Changzhou Waston Medical Appliance Co | WASTON General Spinal System | Nov 18, 2015 |
| K152132 | X-Spine Systems | X-spine Pedicle Screw System | Sep 25, 2015 |
| K151592 | Suzhou Gemmed Medical Instrument Co | Gemmed pedicle screw spinal system | Sep 24, 2015 |
| K152131 | Reliance Medical Systems | Reliance Spinal Screw System | Sep 17, 2015 |
| K152098 | Kisco International | ODALYS Pedicle Screw System | Sep 17, 2015 |
| K152174 | Spine Wave | Sniper Spine System | Aug 31, 2015 |
| K151813 | Spine Wave | Sniper Spine System | Jul 31, 2015 |
| K150294 | Osteomed Implantes, Ltda | DPZ Pedicular Fixation System | Jun 5, 2015 |
| K150647 | New Era Orthopedics | Polyscrew Pedicle Screw System | Apr 8, 2015 |
| K150049 | Medicrea International | PASS LP Spinal System | Feb 10, 2015 |
| K141253 | New Era Orthopaedics | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM | Jan 9, 2015 |