Universal Clamp Stainless Steel System
FDA 510(k) K081622 · Abbott Spine, Inc.
510(k) numberK081622
Submission
- Device name
- Universal Clamp Stainless Steel System
- Applicant
- Abbott Spine, Inc.
Austin, TX, US - Received
- June 10, 2008
- Decision date
- August 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
More from Neos Surgery S.L
| 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 |
| 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 |
| K052638 | Abbott Spine, Inc. Spinnaker SystemKNW · Traditional | 11/07/2005SE |
Questions and answers
When was Universal Clamp Stainless Steel System cleared by the FDA?
Universal Clamp Stainless Steel System (K081622) received a 510(k) decision of Substantially Equivalent on August 29, 2008, 80 days after the submission was received.
What is the product code of K081622?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.