FDA 510(k)

Peridot Intervertebral body fusion System

K-Number: K192026 · 2019-11-26

Decision Date2019-11-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Peridot Intervertebral body fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192026. 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 Peridot Intervertebral body fusion System?

Peridot Intervertebral body fusion System is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K192026.

When did Peridot Intervertebral body fusion System receive FDA 510(k) clearance?

Peridot Intervertebral body fusion System received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192026.

Who is the listed applicant for Peridot Intervertebral body fusion System?

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

What is the FDA product code for Peridot Intervertebral body fusion System?

The FDA product code for Peridot Intervertebral body fusion System is MAX.

Other records listing Gbs Commonwealth 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.

View all 14 devices →

Related Devices (Code: MAX)

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 Corporation K253151Fule 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.