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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 the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) 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. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K241738.

When did PYXIS 3D Titanium Cervical Cage system receive FDA 510(k) clearance?

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

Who is the listed applicant for PYXIS 3D Titanium Cervical Cage system?

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

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.

Other records listing GS 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.

K243073AnyPlus Navigated Instruments SystemK240350AnyPlus II Spinal Fixation SystemK231808QUASAR Standalone ACIF SystemK223868PYXIS 3D Titanium Cage SystemK222041CYGNUS-C Standalone ACIF SystemK221687Pegasus-X Expandable PLIF System

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Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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