Synex II
FDA 510(k) K061891 · Synthes Spine Co.Lp
510(k) numberK061891
Submission
- Device name
- Synex II
- Applicant
- Synthes Spine Co.Lp
West Chester, PA, US - Received
- July 3, 2006
- Decision date
- August 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code MQP
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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 |
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| K111048 | Synthes Scout Tack FixationOMR · Traditional | 06/14/2012SESU |
| K120928 | Synthes Matrix SystemNKB · Traditional | 05/18/2012SE |
| K120571 | Synthes Uss ConnectorNKB · Traditional | 05/14/2012SE |
| K113149 | Synthes Uss ConnectorsMNI · Traditional | 02/01/2012SE |
| K113044 | Synthes MirsNKB · Traditional | 12/21/2011SE |
| K112459 | Synthes Zero-POVE · Special | 12/12/2011SE |
| K111358 | Synthes UssNKB · Traditional | 11/18/2011SE |
Questions and answers
When was Synex II cleared by the FDA?
Synex II (K061891) received a 510(k) decision of Substantially Equivalent on August 18, 2006, 46 days after the submission was received.
What is the product code of K061891?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.