Plus Pivot Link Universal System
FDA 510(k) K032398 · Spine Vision, Inc.
510(k) numberK032398
Submission
- Device name
- Plus Pivot Link Universal System
- Applicant
- Spine Vision, Inc.
Atlanta, GA, US - Received
- August 4, 2003
- Decision date
- October 31, 2003
- 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
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 |
|---|---|---|
| K052406 | Uni-Thread Spinal SystemMNI · Traditional | 11/07/2005SE |
| K030526 | Pediguard Nerve Detector SystemGWF · Traditional | 12/29/2004SE |
| K042930 | Spacevision Cage SystemMQP · Traditional | 12/28/2004SE |
| K042640 | Uni-Thread Spinal SystemMNH · Traditional | 11/23/2004SE |
| K033508 | Plus Pivot Link Universal SystemMNI · Traditional | 01/27/2004SE |
| K022271 | Plus Pivot Link Universal SystemMNI · Traditional | 09/23/2002SE |
| K021510 | Uni-T Uni-Thread Spinal SystemMNI · Traditional | 08/01/2002SE |
| K021507 | Plus Pivot Link Universal SystemKWP · Traditional | 08/01/2002SE |
| K013312 | P.L.U.S. System (Pivot Link Universal System)KWP · Traditional | 02/13/2002SE |
| K013301 | Uni-T Spinal SystemMNI · Traditional | 02/13/2002SE |
Questions and answers
When was Plus Pivot Link Universal System cleared by the FDA?
Plus Pivot Link Universal System (K032398) received a 510(k) decision of Substantially Equivalent on October 31, 2003, 88 days after the submission was received.
What is the product code of K032398?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.