Kyphon Inflatable Bone Tamp
FDA 510(k) K981251 · Kyphon, Inc.
510(k) numberK981251
Submission
- Device name
- Kyphon Inflatable Bone Tamp
- Applicant
- Kyphon, Inc.
Santa Clara, CA, US - Received
- April 6, 1998
- Decision date
- July 2, 1998
- 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 |
|---|---|---|
| K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…BSP · Traditional | 02/21/2008SE |
| K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BBSP · Special | 04/13/2007SE |
| K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…BSP · Special | 06/27/2006SE |
| K041454 | Kyphx Xpander Inflatable Bone Tamps MODEL#KO8A,KO9A,K13AHRX · Traditional | 07/09/2004SE |
| K041584 | Kyphx Hv-R Bone Cement, Model C01ANDN · Traditional | 07/07/2004SE |
| K033801 | Kyphx Hv-R, Model C01ANDN · Traditional | 04/01/2004SE |
| K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AHRX · Traditional | 09/15/2003SE |
| K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,MODEL K01A, Kyphx Inflatable Bone Tamp, Size 15/3…HRX · Traditional | 02/14/2001SE |
Questions and answers
When was Kyphon Inflatable Bone Tamp cleared by the FDA?
Kyphon Inflatable Bone Tamp (K981251) received a 510(k) decision of Substantially Equivalent on July 2, 1998, 87 days after the submission was received.
What is the product code of K981251?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.