P.L.U.S. System (Pivot Link Universal System)
FDA 510(k) K013312 · Spine Vision, Inc.
510(k) numberK013312
Submission
- Device name
- P.L.U.S. System (Pivot Link Universal System)
- Applicant
- Spine Vision, Inc.
Atlanta, GA, US - Received
- October 4, 2001
- Decision date
- February 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 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 |
| K032398 | Plus Pivot Link Universal SystemMNI · Traditional | 10/31/2003SE |
| 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 |
| K013301 | Uni-T Spinal SystemMNI · Traditional | 02/13/2002SE |
Questions and answers
When was P.L.U.S. System (Pivot Link Universal System) cleared by the FDA?
P.L.U.S. System (Pivot Link Universal System) (K013312) received a 510(k) decision of Substantially Equivalent on February 13, 2002, 132 days after the submission was received.
What is the product code of K013312?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.