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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-12-07 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K231515.
When was MySpine Cervical Guides approved by the FDA?
MySpine Cervical Guides received FDA 510(k) clearance on 2023-12-07, under approval number K231515.
What company makes MySpine Cervical Guides?
MySpine Cervical Guides is manufactured by Medacta International S.A..
What is the FDA product code for MySpine Cervical Guides?
The FDA product code for MySpine Cervical Guides is QSD.
Other Devices by Medacta International S.A.
Related Devices (Code: QSD)
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.