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FDA 510(k)

TECHFIT Patient-Specific Cranial System

K-Number: K250297 · 2025-10-27

ApplicantTechfit Digital Surgery, Inc.
Decision Date2025-10-27
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECHFIT Patient-Specific Cranial System is a medical device manufactured by Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2025-10-27 under approval number K250297. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHFIT Patient-Specific Cranial System?

TECHFIT Patient-Specific Cranial System is a medical device that received FDA 510(k) clearance on 2025-10-27. It is manufactured by Techfit Digital Surgery, Inc.. The 510(k) number is K250297.

When was TECHFIT Patient-Specific Cranial System approved by the FDA?

TECHFIT Patient-Specific Cranial System received FDA 510(k) clearance on 2025-10-27, under approval number K250297.

What company makes TECHFIT Patient-Specific Cranial System?

TECHFIT Patient-Specific Cranial System is manufactured by Techfit Digital Surgery, Inc..

What is the FDA product code for TECHFIT Patient-Specific Cranial System?

The FDA product code for TECHFIT Patient-Specific Cranial System is GWO.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Other Devices by Techfit Digital Surgery, Inc.

K220199AFFINITY Proximal Tibia System K222577TECHFIT Diagnostic Models K242263TECHFIT DISRP® System

Related Devices (Code: GWO)

K161821Stryker Universal MeshStryker K161446Biopor Porous Polyethylene ImplantsCeremed , Inc. K153248PEEK Customized Cranial ImplantStryker K170725Stryker Universal MeshStryker K170368Sterile NS SystemJeil Medical Corporation K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG

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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