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FDA 510(k)

Expandable Lumbar Fusion Cage (Type I,Type II)

K-Number: K232069 · 2023-11-29

ApplicantShanghai Reach Medical Instrument Co, Ltd.
Decision Date2023-11-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Expandable Lumbar Fusion Cage (Type I,Type II) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232069. 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 Expandable Lumbar Fusion Cage (Type I,Type II)?

Expandable Lumbar Fusion Cage (Type I,Type II) is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. The 510(k) number is K232069.

When did Expandable Lumbar Fusion Cage (Type I,Type II) receive FDA 510(k) clearance?

Expandable Lumbar Fusion Cage (Type I,Type II) received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232069.

Who is the listed applicant for Expandable Lumbar Fusion Cage (Type I,Type II)?

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

What is the FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II)?

The FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II) is MAX.

Related Clinical Trials

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.

NCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING

Other records listing Shanghai Reach Medical Instrument 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.

K221745Sterile Posterior Spinal Fixation SystemK201737Posterior Spinal Fixation System

Related Devices (Code: MAX)

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.

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 CorporationK253151Fule 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.

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