Reliance Spinal Screw System
FDA 510(k) K152131 · Reliance Medical Systems, LLC
510(k) numberK152131
Submission
- Device name
- Reliance Spinal Screw System
- Applicant
- Reliance Medical Systems, LLC
Bountiful, UT, US - Received
- July 31, 2015
- Decision date
- September 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| K202266 | Reliance Cervical IBF SystemODP · Traditional | 03/29/2022SE |
| K210874 | Reliance Spinal Screw SystemNKB · Special | 05/13/2021SE |
| K183049 | Reliance Lumbar IBF SystemMAX · Special | 02/15/2019SE |
| K181118 | Reliance Lumbar IBF SystemOVD · Traditional | 01/09/2019SE |
| K180687 | Reliance Lumber IBF SystemMAX · Special | 05/15/2018SE |
| K173283 | Reliance Lumbar IBF SystemMAX · Special | 01/19/2018SE |
| K173102 | Reliance Cervical IBF SystemODP · Special | 12/29/2017SE |
| K172489 | Reliance Cervical IBF SystemODP · Special | 09/07/2017SE |
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | 12/02/2016SE |
| K160463 | Reliance Lumbar IBF SystemMAX · Special | 05/20/2016SE |
Questions and answers
When was Reliance Spinal Screw System cleared by the FDA?
Reliance Spinal Screw System (K152131) received a 510(k) decision of Substantially Equivalent on September 17, 2015, 48 days after the submission was received.
What is the product code of K152131?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.