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FDA 510(k)

DZ-Tabone Intervertebral Body Fusion Device

K-Number: K241073 · 2024-12-06

ApplicantShenzhen Dazhou Medical Technology Co., Ltd.
Decision Date2024-12-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DZ-Tabone Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dazhou Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241073. 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 DZ-Tabone Intervertebral Body Fusion Device?

DZ-Tabone Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Shenzhen Dazhou Medical Technology Co., Ltd.. The 510(k) number is K241073.

When did DZ-Tabone Intervertebral Body Fusion Device receive FDA 510(k) clearance?

DZ-Tabone Intervertebral Body Fusion Device received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241073.

Who is the listed applicant for DZ-Tabone Intervertebral Body Fusion Device?

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

What is the FDA product code for DZ-Tabone Intervertebral Body Fusion Device?

The FDA product code for DZ-Tabone Intervertebral Body Fusion Device is MAX.

Other records listing Shenzhen Dazhou Medical Technology 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.

K241186Synthetic Bone Graft Particulate

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.

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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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