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FDA 510(k)

Surgical Drive System (Model: ES70, ES90, E8)

K-Number: K240340 · 2024-07-18

ApplicantGuangdong Jinme Medical Technology Co., Ltd.
Decision Date2024-07-18
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Drive System (Model: ES70, ES90, E8) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K240340. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Drive System (Model: ES70, ES90, E8)?

Surgical Drive System (Model: ES70, ES90, E8) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K240340.

When did Surgical Drive System (Model: ES70, ES90, E8) receive FDA 510(k) clearance?

Surgical Drive System (Model: ES70, ES90, E8) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K240340.

Who is the listed applicant for Surgical Drive System (Model: ES70, ES90, E8)?

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

What is the FDA product code for Surgical Drive System (Model: ES70, ES90, E8)?

The FDA product code for Surgical Drive System (Model: ES70, ES90, E8) is DZI.

Other records listing Guangdong Jinme 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.

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Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLCK192561TRAUS SUS20Saeshin Precision Co., Ltd.

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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