Vusion TS, PS, and CS Partial Vertebral Body Replacements
FDA 510(k) K062666 · Ortho Development Corp.
510(k) numberK062666
Submission
- Device name
- Vusion TS, PS, and CS Partial Vertebral Body Replacements
- Applicant
- Ortho Development Corp.
Draper, UT, US - Received
- September 7, 2006
- Decision date
- January 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
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| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
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| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
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Questions and answers
When was Vusion TS, PS, and CS Partial Vertebral Body Replacements cleared by the FDA?
Vusion TS, PS, and CS Partial Vertebral Body Replacements (K062666) received a 510(k) decision of Substantially Equivalent on January 25, 2007, 140 days after the submission was received.
What is the product code of K062666?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.