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FDA 510(k)

TECHFIT Patient-Specific Maxillofacial System

K-Number: K203282 · 2021-05-19

ApplicantIndustrias Medicas Sampedro S.A.S
Decision Date2021-05-19
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TECHFIT Patient-Specific Maxillofacial System is a medical device manufactured by Industrias Medicas Sampedro S.A.S. It received FDA 510(k) clearance on 2021-05-19 under approval number K203282. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHFIT Patient-Specific Maxillofacial System?

TECHFIT Patient-Specific Maxillofacial System is a medical device that received FDA 510(k) clearance on 2021-05-19. It is manufactured by Industrias Medicas Sampedro S.A.S. The 510(k) number is K203282.

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

TECHFIT Patient-Specific Maxillofacial System received FDA 510(k) clearance on 2021-05-19, under approval number K203282.

What company makes TECHFIT Patient-Specific Maxillofacial System?

TECHFIT Patient-Specific Maxillofacial System is manufactured by Industrias Medicas Sampedro S.A.S.

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

The FDA product code for TECHFIT Patient-Specific Maxillofacial System is JEY.

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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 Industrias Medicas Sampedro S.A.S

K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

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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