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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 the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2025-12-08 under 510(k) 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. The listed applicant is Degen Medical. The 510(k) number is K251829.

When did DeGen Medical Patient Specific Implant (PSI) System receive FDA 510(k) clearance?

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

Who is the listed applicant for DeGen Medical Patient Specific Implant (PSI) System?

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

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.

Other records listing Degen Medical 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.

K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemK250667DeGen Medical Patient Specific Implant (PSI) SystemK241077DeGen Medical Patient Specific Implant (PSI) SystemK240326Solar™ Lumbar Interbody Fusion SystemK231199Solar Lumbar Interbody Fusion SystemK223418DeGen Impulse AM™ System

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

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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