Shanghai Sanyou PEEK Cage System
FDA 510(k) K163422 · Shanghai Sanyou Medical Co, Ltd.
510(k) numberK163422
Submission
- Device name
- Shanghai Sanyou PEEK Cage System
- Applicant
- Shanghai Sanyou Medical Co, Ltd.
Jiading District, CN - Received
- December 6, 2016
- Decision date
- September 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction…MAX · Traditional | 12/12/2023SE |
| K230961 | Zeus Spinal SystemNKB · Special | 10/10/2023SE |
| K231931 | Adena-Zina Spinal SystemNKB · Special | 07/28/2023SE |
| K211689 | KEYSTONE PEEK Cage SystemMAX · Traditional | 09/21/2021SE |
| K212066 | Adena-Zina SystemNKB · Traditional | 08/16/2021SE |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion SystemKWQ · Traditional | 10/05/2017SE |
| K152781 | Adena-Zina SystemNKB · Traditional | 02/12/2016SE |
| K131512 | Katia SystemKWQ · Traditional | 08/07/2013SE |
Questions and answers
When was Shanghai Sanyou PEEK Cage System cleared by the FDA?
Shanghai Sanyou PEEK Cage System (K163422) received a 510(k) decision of Substantially Equivalent on September 18, 2017, 286 days after the submission was received.
What is the product code of K163422?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.