Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series
FDA 510(k) K060634 · Abbott Spine, Inc.
510(k) numberK060634
Submission
- Device name
- Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series
- Applicant
- Abbott Spine, Inc.
Austin, TX, US - Received
- March 9, 2006
- Decision date
- March 31, 2006
- 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 |
|---|---|---|
| K090060 | Nexlink Oct System, Model 7000 SeriesKWP · Traditional | 06/02/2009SE |
| K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…NKB · Traditional | 10/06/2008SE |
| K081622 | Universal Clamp Stainless Steel SystemJDQ · Special | 08/29/2008SE |
| K073202 | Ardis SpacerMAX · Traditional | 01/30/2008SE |
| K072672 | Sequoia Spinal System, Model 3300 SeriesNKB · Special | 11/28/2007SE |
| K071174 | Pathfinder System Polyaxial Pedicle ScrewsNKB · Special | 07/25/2007SE |
| K062505 | Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesMNI · Special | 09/26/2006SE |
| K060009 | Abbott Spine Universal Clamp SystemJDQ · Special | 03/06/2006SE |
| K052566 | Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119…MNI · Special | 01/06/2006SE |
| K052638 | Abbott Spine, Inc. Spinnaker SystemKNW · Traditional | 11/07/2005SE |
Questions and answers
When was Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series cleared by the FDA?
Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series (K060634) received a 510(k) decision of Substantially Equivalent on March 31, 2006, 22 days after the submission was received.
What is the product code of K060634?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.