Abbott Spine, Inc. Spinnaker System
FDA 510(k) K052638 · Abbott Spine, Inc.
510(k) numberK052638
Submission
- Device name
- Abbott Spine, Inc. Spinnaker System
- Applicant
- Abbott Spine, Inc.
Austin, TX, US - Received
- September 26, 2005
- Decision date
- November 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
More from Forcyte Medical, LLC
| 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 Abbott Spine, Inc. Spinnaker System cleared by the FDA?
Abbott Spine, Inc. Spinnaker System (K052638) received a 510(k) decision of Substantially Equivalent on November 7, 2005, 42 days after the submission was received.
What is the product code of K052638?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.