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FDA 510(k)

Shanghai Sanyou PEEK Cage System

K-Number: K163422 · 2017-09-18

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2017-09-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shanghai Sanyou PEEK Cage System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-09-18 under approval number K163422. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shanghai Sanyou PEEK Cage System?

Shanghai Sanyou PEEK Cage System is a medical device that received FDA 510(k) clearance on 2017-09-18. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163422.

When was Shanghai Sanyou PEEK Cage System approved by the FDA?

Shanghai Sanyou PEEK Cage System received FDA 510(k) clearance on 2017-09-18, under approval number K163422.

What company makes Shanghai Sanyou PEEK Cage System?

Shanghai Sanyou PEEK Cage System is manufactured by Shanghai Sanyou Medical Co, Ltd..

What is the FDA product code for Shanghai Sanyou PEEK Cage System?

The FDA product code for Shanghai Sanyou PEEK Cage System is ODP.

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Other Devices by Shanghai Sanyou Medical Co, Ltd.

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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