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FDA 510(k)

MySpine Cervical Guides

K-Number: K231515 · 2023-12-07

ApplicantMedacta International S.A.
Decision Date2023-12-07
Product CodeQSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine Cervical Guides is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2023-12-07 under 510(k) number K231515. The device is classified under product code QSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySpine Cervical Guides?

MySpine Cervical Guides is a medical device that received FDA 510(k) clearance on 2023-12-07. The listed applicant is Medacta International S.A.. The 510(k) number is K231515.

When did MySpine Cervical Guides receive FDA 510(k) clearance?

MySpine Cervical Guides received FDA 510(k) clearance on 2023-12-07, under 510(k) number K231515.

Who is the listed applicant for MySpine Cervical Guides?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySpine Cervical Guides?

The FDA product code for MySpine Cervical Guides is QSD.

Other records listing Medacta International S.A. as applicant

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Related Devices (Code: QSD)

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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