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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-09-21 under 510(k) 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. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K211689.

When did KEYSTONE PEEK Cage System receive FDA 510(k) clearance?

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

Who is the listed applicant for KEYSTONE PEEK Cage System?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shanghai Sanyou Medical Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage SystemK230961Zeus Spinal SystemK231931Adena-Zina Spinal SystemK212066Adena-Zina SystemK163366Shanghai Sanyou CARMEN Cervical Fusion SystemK163422Shanghai Sanyou PEEK Cage System

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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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