MySpine Unilateral Guides
K-Number: K231483 · 2023-07-21
ApplicantMedacta International S.A.
Decision Date2023-07-21
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MySpine Unilateral Guides is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-07-21 under approval number K231483. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MySpine Unilateral Guides?
MySpine Unilateral Guides is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Medacta International S.A.. The 510(k) number is K231483.
When was MySpine Unilateral Guides approved by the FDA?
MySpine Unilateral Guides received FDA 510(k) clearance on 2023-07-21, under approval number K231483.
What company makes MySpine Unilateral Guides?
MySpine Unilateral Guides is manufactured by Medacta International S.A..
What is the FDA product code for MySpine Unilateral Guides?
The FDA product code for MySpine Unilateral Guides is PQC.
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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.