Reform Pedicle Screw System
FDA 510(k) K131343 · Spinal USA
510(k) numberK131343
Submission
- Device name
- Reform Pedicle Screw System
- Applicant
- Spinal USA
Colorado Springs, CO, US - Received
- May 9, 2013
- Decision date
- July 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
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| K132029 | Vault-C Intervertebral Body Fusion DeviceOVE · Traditional | 11/25/2013SE |
| K130863 | Facet Screw SystemMRW · Traditional | 08/09/2013SE |
| K130279 | Reform Pedicle Screw SystemMNI · Traditional | 06/20/2013SE |
| K130445 | Vault Alif SystemOVD · Special | 04/25/2013SE |
| K122931 | S-Lok PSS SystemMNI · Traditional | 11/20/2012SE |
| K121172 | Reform Pedicle Screw SystemMNI · Special | 08/08/2012SE |
| K112748 | Slimplicity Solo Anterior Cervical Plate SystemKWQ · Traditional | 07/11/2012SE |
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Traditional | 09/15/2011SE |
| K103369 | Vault Alif SystemOVD · Traditional | 04/04/2011SE |
| K092659 | Spinal USA RCS Anterior Lumbar Butress Plate System, Model 22-1001-25KWQ · Traditional | 11/17/2009SE |
Questions and answers
When was Reform Pedicle Screw System cleared by the FDA?
Reform Pedicle Screw System (K131343) received a 510(k) decision of Substantially Equivalent on July 24, 2013, 76 days after the submission was received.
What is the product code of K131343?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.