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FDA 510(k)

Peridot Spinal Interbody System

K-Number: K213980 · 2022-03-15

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2022-03-15
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Peridot Spinal Interbody System is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2022-03-15 under approval number K213980. 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 Peridot Spinal Interbody System?

Peridot Spinal Interbody System is a medical device that received FDA 510(k) clearance on 2022-03-15. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K213980.

When was Peridot Spinal Interbody System approved by the FDA?

Peridot Spinal Interbody System received FDA 510(k) clearance on 2022-03-15, under approval number K213980.

What company makes Peridot Spinal Interbody System?

Peridot Spinal Interbody System is manufactured by Gbs Commonwealth Co., Ltd..

What is the FDA product code for Peridot Spinal Interbody System?

The FDA product code for Peridot Spinal Interbody System is ODP.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Gbs Commonwealth Co., Ltd.

K182059Prase MIS Spinal System K173645JASPER Spinal Fixation System K192026Peridot Intervertebral body fusion System K190762The JASPER Spinal Fixation System II K211205Prase-C Anterior Cervical Plate System K202872Prase PEEK Anterior Cervical Interbody Spacer

View all 14 devices →

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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