Synthes Patient Specific Implants
K-Number: K243715 · 2025-11-12
ApplicantSynthes GmbH
Decision Date2025-11-12
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Synthes Patient Specific Implants is a medical device manufactured by Synthes GmbH. It received FDA 510(k) clearance on 2025-11-12 under approval number K243715. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synthes Patient Specific Implants?
Synthes Patient Specific Implants is a medical device that received FDA 510(k) clearance on 2025-11-12. It is manufactured by Synthes GmbH. The 510(k) number is K243715.
When was Synthes Patient Specific Implants approved by the FDA?
Synthes Patient Specific Implants received FDA 510(k) clearance on 2025-11-12, under approval number K243715.
What company makes Synthes Patient Specific Implants?
Synthes Patient Specific Implants is manufactured by Synthes GmbH.
What is the FDA product code for Synthes Patient Specific Implants?
The FDA product code for Synthes Patient Specific Implants is GXN.
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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.