Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XX
FDA 510(k) K052247 · Abbott Spine, Inc.
510(k) numberK052247
Submission
- Device name
- Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XX
- Applicant
- Abbott Spine, Inc.
Austin, TX, US - Received
- August 18, 2005
- Decision date
- September 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| 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 |
| K060634 | Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 SeriesMNI · Traditional | 03/31/2006SE |
| 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 |
Questions and answers
When was Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XX cleared by the FDA?
Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XX (K052247) received a 510(k) decision of Substantially Equivalent on September 14, 2005, 27 days after the submission was received.
What is the product code of K052247?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.