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FDA 510(k)

Peridot-EX Expandable Intervertebral Body Fusion System

K-Number: K232292 · 2023-11-07

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2023-11-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Peridot-EX Expandable Intervertebral Body Fusion System is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under approval number K232292. 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-EX Expandable Intervertebral Body Fusion System?

Peridot-EX Expandable Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2023-11-07. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K232292.

When was Peridot-EX Expandable Intervertebral Body Fusion System approved by the FDA?

Peridot-EX Expandable Intervertebral Body Fusion System received FDA 510(k) clearance on 2023-11-07, under approval number K232292.

What company makes Peridot-EX Expandable Intervertebral Body Fusion System?

Peridot-EX Expandable Intervertebral Body Fusion System is manufactured by Gbs Commonwealth Co., Ltd..

What is the FDA product code for Peridot-EX Expandable Intervertebral Body Fusion System?

The FDA product code for Peridot-EX Expandable Intervertebral Body Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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

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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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