Staxx FX System
FDA 510(k) K053336 · Spine Wave, Inc.
510(k) numberK053336
Submission
- Device name
- Staxx FX System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- December 1, 2005
- Decision date
- July 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional | Xelite Biomed , Ltd. | 09/18/2024SE |
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More from Tecres S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | 05/29/2026SE |
| K243816 | Testa TP Pivoting Spacer SystemMAX · Traditional | 06/27/2025SE |
| K251131 | Annex® 2 Adjacent Level SystemNKB · Traditional | 06/06/2025SE |
| K243514 | Salvo® Robotic Navigation InstrumentsOLO · Traditional | 04/03/2025SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | 05/06/2024SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
| K222362 | Salvo® Spine SystemNKB · Special | 08/29/2022SE |
| K202476 | Salvo® Spine SystemNKB · Traditional | 11/05/2020SE |
| K192526 | Spine Wave Navigated InstrumentsOLO · Special | 10/10/2019SE |
Questions and answers
When was Staxx FX System cleared by the FDA?
Staxx FX System (K053336) received a 510(k) decision of Substantially Equivalent on July 3, 2006, 214 days after the submission was received.
What is the product code of K053336?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.