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FDA 510(k)

MS SA IMPLANT SYSTEM

K-Number: K122171 · 2012-11-16

ApplicantOsstem Implant Co., Ltd.
Decision Date2012-11-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MS SA IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2012-11-16 under 510(k) number K122171. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS SA IMPLANT SYSTEM?

MS SA IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-16. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K122171.

When did MS SA IMPLANT SYSTEM receive FDA 510(k) clearance?

MS SA IMPLANT SYSTEM received FDA 510(k) clearance on 2012-11-16, under 510(k) number K122171.

Who is the listed applicant for MS SA IMPLANT SYSTEM?

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

What is the FDA product code for MS SA IMPLANT SYSTEM?

The FDA product code for MS SA IMPLANT SYSTEM is DZE.

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Other records listing Osstem Implant Co., Ltd. as applicant

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Related Devices (Code: DZE)

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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