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FDA 510(k)

PYXIS 3D Titanium Cervical Cage system

K-Number: K241738 · 2024-08-20

ApplicantGS Medical Co., Ltd.
Decision Date2024-08-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYXIS 3D Titanium Cervical Cage system is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under approval number K241738. 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 PYXIS 3D Titanium Cervical Cage system?

PYXIS 3D Titanium Cervical Cage system is a medical device that received FDA 510(k) clearance on 2024-08-20. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K241738.

When was PYXIS 3D Titanium Cervical Cage system approved by the FDA?

PYXIS 3D Titanium Cervical Cage system received FDA 510(k) clearance on 2024-08-20, under approval number K241738.

What company makes PYXIS 3D Titanium Cervical Cage system?

PYXIS 3D Titanium Cervical Cage system is manufactured by GS Medical Co., Ltd..

What is the FDA product code for PYXIS 3D Titanium Cervical Cage system?

The FDA product code for PYXIS 3D Titanium Cervical Cage system is ODP.

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Other Devices by GS Medical Co., Ltd.

K153517AnyPlus® Cervical PEEK Cage System K172546AnyPlus® Spinal Fixation System K192335TRACKER Kyphoplasty System K190170MVP Cervical Plate System K200592GS Medical AnyPlus PEEK Cage System K211797TRACKER Plus Kyphoplasty System

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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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