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FDA 510(k)

DeGen Medical Patient Specific Implant (PSI) System

K-Number: K251829 · 2025-12-08

ApplicantDegen Medical
Decision Date2025-12-08
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DeGen Medical Patient Specific Implant (PSI) System is a medical device manufactured by Degen Medical. It received FDA 510(k) clearance on 2025-12-08 under approval number K251829. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeGen Medical Patient Specific Implant (PSI) System?

DeGen Medical Patient Specific Implant (PSI) System is a medical device that received FDA 510(k) clearance on 2025-12-08. It is manufactured by Degen Medical. The 510(k) number is K251829.

When was DeGen Medical Patient Specific Implant (PSI) System approved by the FDA?

DeGen Medical Patient Specific Implant (PSI) System received FDA 510(k) clearance on 2025-12-08, under approval number K251829.

What company makes DeGen Medical Patient Specific Implant (PSI) System?

DeGen Medical Patient Specific Implant (PSI) System is manufactured by Degen Medical.

What is the FDA product code for DeGen Medical Patient Specific Implant (PSI) System?

The FDA product code for DeGen Medical Patient Specific Implant (PSI) System is OVD.

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Related PubMed Literature

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Other Devices by Degen Medical

K160926F1 MPS Modular Pedicle Screw System K173814DeGen Medical E3 MIS Pedicle Screw System K201287Impulse Interbody Fusion System K210090Impulse AM Interbody Fusion System K203816DeGen Navigated Instrumentation K213918DeGen Navigated Instrumentation

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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.

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