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FDA 510(k)

DeGen Medical Patient Specific Implant (PSI) System

K-Number: K250667 · 2025-04-04

ApplicantDegen Medical
Decision Date2025-04-04
Product CodeMAX
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 2025-04-04 under 510(k) number K250667. The device is classified under product code MAX. 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 2025-04-04. The listed applicant is Degen Medical. The 510(k) number is K250667.

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 2025-04-04, under 510(k) number K250667.

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 MAX.

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.

K251829DeGen Medical Patient Specific Implant (PSI) SystemK252737DeGen Medical Latitude-C AM Cervical Interbody Fusion 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: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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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