Synthes Synex Spacer System
FDA 510(k) K003836 · Synthes
510(k) numberK003836
Submission
- Device name
- Synthes Synex Spacer System
- Applicant
- Synthes
Paoli, PA, US - Received
- December 12, 2000
- Decision date
- May 29, 2001
- 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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| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
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Questions and answers
When was Synthes Synex Spacer System cleared by the FDA?
Synthes Synex Spacer System (K003836) received a 510(k) decision of Substantially Equivalent on May 29, 2001, 168 days after the submission was received.
What is the product code of K003836?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.