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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2025-11-12 under 510(k) 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. The listed applicant is Synthes GmbH. The 510(k) number is K243715.

When did Synthes Patient Specific Implants receive FDA 510(k) clearance?

Synthes Patient Specific Implants received FDA 510(k) clearance on 2025-11-12, under 510(k) number K243715.

Who is the listed applicant for Synthes Patient Specific Implants?

The FDA 510(k) record lists Synthes GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthes Patient Specific Implants?

The FDA product code for Synthes Patient Specific Implants is GXN.

Other records listing Synthes GmbH as applicant

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.

View all 7 devices →

Related Devices (Code: GXN)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.