Co Vertebral Body Replacement
FDA 510(k) K050348 · Scient'X
510(k) numberK050348
Submission
- Device name
- Co Vertebral Body Replacement
- Applicant
- Scient'X
Round Rock, TX, US - Received
- February 11, 2005
- Decision date
- May 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| 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 |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K071261 | Isobar Semi-Rigid Dual DampenerNQP · Traditional | 04/17/2008SE |
| K062912 | Scient'X Spinal SystemMNI · Special | 02/05/2007SE |
| K052763 | Stella Cervical PlateKWQ · Special | 11/10/2005SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | 10/05/2005SESU |
| K051063 | Polyaxial Hemispherical Spinal ScrewsMNI · Special | 05/23/2005SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | 12/01/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | 11/22/2004SE |
| K042317 | Cervical PlateKWQ · Special | 09/24/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | 06/17/2004SE |
| K040454 | Biofill Bone Void FillerMQV · Traditional | 05/07/2004SE |
Questions and answers
When was Co Vertebral Body Replacement cleared by the FDA?
Co Vertebral Body Replacement (K050348) received a 510(k) decision of Substantially Equivalent on May 27, 2005, 105 days after the submission was received.
What is the product code of K050348?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.