FDA 510(k)

TECHFIT DISRP® System

K-Number: K242263 · 2024-12-11

Decision Date2024-12-11

Product CodeDZJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TECHFIT DISRP® System is a medical device manufactured by Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2024-12-11 under approval 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. It is manufactured by Techfit Digital Surgery, Inc.. The 510(k) number is K242263.

When was TECHFIT DISRP® System approved by the FDA?

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

What company makes TECHFIT DISRP® System?

TECHFIT DISRP® System is manufactured by Techfit Digital Surgery, Inc..

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

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

Other Devices by Techfit Digital Surgery, Inc.

K220199AFFINITY Proximal Tibia System K222577TECHFIT Diagnostic Models K250297TECHFIT Patient-Specific Cranial System

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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.