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FDA 510(k)

TECHFIT DISRP® System

K-Number: K242263 · 2024-12-11

ApplicantTechfit Digital Surgery, Inc.
Decision Date2024-12-11
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TECHFIT DISRP® System is the device name listed in this FDA 510(k) record. The listed applicant is Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K242263. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHFIT DISRP® System?

TECHFIT DISRP® System is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K242263.

When did TECHFIT DISRP® System receive FDA 510(k) clearance?

TECHFIT DISRP® System received FDA 510(k) clearance on 2024-12-11, under 510(k) number K242263.

Who is the listed applicant for TECHFIT DISRP® System?

The FDA 510(k) record lists Techfit Digital Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHFIT DISRP® System?

The FDA product code for TECHFIT DISRP® System is DZJ.

Other records listing Techfit Digital Surgery, Inc. 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.

K250297TECHFIT Patient-Specific Cranial SystemK230276TECHFIT DISRP® SystemK222577TECHFIT Diagnostic ModelsK220199AFFINITY Proximal Tibia System

Related Devices (Code: DZJ)

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.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcadK220366EmbedMed3D Lifeprints UK , Ltd.

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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