X-Void, Spider
FDA 510(k) K072198 · Sintea Biotech, Inc.
510(k) numberK072198
Submission
- Device name
- X-Void, Spider
- Applicant
- Sintea Biotech, Inc.
Miami Beach, FL, US - Received
- August 7, 2007
- Decision date
- June 6, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | 04/07/2009SE |
| K081631 | Sintea Biotech PLS Multi-Axial ScrewsMNH · Special | 07/18/2008SE |
| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | 04/18/2007SE |
| K060513 | Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.XKWP · Special | 03/10/2006SE |
| K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…KWP · Special | 12/17/2004SE |
| K041989 | Sintea Biotech Anterior Plate System, Model ACP.XX.T5.XKWQ · Traditional | 09/16/2004SE |
| K031154 | Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.XJDW · Traditional | 06/24/2003SE |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | 12/10/2002SE |
| K022065 | Sintea Biotech Traumafix System, Model TFX.00.00.XJEC · Traditional | 08/06/2002SE |
Questions and answers
When was X-Void, Spider cleared by the FDA?
X-Void, Spider (K072198) received a 510(k) decision of Substantially Equivalent on June 6, 2008, 304 days after the submission was received.
What is the product code of K072198?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.