MyShoulder Planner (5.3SSWPL)
K-Number: K241292 · 2025-01-30
ApplicantMedacta International S.A.
Decision Date2025-01-30
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MyShoulder Planner (5.3SSWPL) is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-01-30 under approval number K241292. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MyShoulder Planner (5.3SSWPL)?
MyShoulder Planner (5.3SSWPL) is a medical device that received FDA 510(k) clearance on 2025-01-30. It is manufactured by Medacta International S.A.. The 510(k) number is K241292.
When was MyShoulder Planner (5.3SSWPL) approved by the FDA?
MyShoulder Planner (5.3SSWPL) received FDA 510(k) clearance on 2025-01-30, under approval number K241292.
What company makes MyShoulder Planner (5.3SSWPL)?
MyShoulder Planner (5.3SSWPL) is manufactured by Medacta International S.A..
What is the FDA product code for MyShoulder Planner (5.3SSWPL)?
The FDA product code for MyShoulder Planner (5.3SSWPL) is KWS.
Other Devices by Medacta International S.A.
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K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.
K161108Arthrex VaultLock GlenoidArthrex, Inc.
K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.
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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.