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FDA 510(k)

KEYSTONE PEEK Cage System

K-Number: K211689 · 2021-09-21

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2021-09-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KEYSTONE PEEK Cage System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-09-21 under approval number K211689. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEYSTONE PEEK Cage System?

KEYSTONE PEEK Cage System is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K211689.

When was KEYSTONE PEEK Cage System approved by the FDA?

KEYSTONE PEEK Cage System received FDA 510(k) clearance on 2021-09-21, under approval number K211689.

What company makes KEYSTONE PEEK Cage System?

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

What is the FDA product code for KEYSTONE PEEK Cage System?

The FDA product code for KEYSTONE PEEK Cage System is MAX.

Other Devices by Shanghai Sanyou Medical Co, Ltd.

K152781Adena-Zina System K163366Shanghai Sanyou CARMEN Cervical Fusion System K163422Shanghai Sanyou PEEK Cage System K212066Adena-Zina System K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System K230961Zeus Spinal System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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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