FDA 510(k)

EmbedMed

K-Number: K220366 · 2022-09-30

Decision Date2022-09-30

Product CodeDZJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EmbedMed is the device name listed in this FDA 510(k) record. The listed applicant is 3D Lifeprints UK , Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220366. 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 EmbedMed?

EmbedMed is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is 3D Lifeprints UK , Ltd.. The 510(k) number is K220366.

When did EmbedMed receive FDA 510(k) clearance?

EmbedMed received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220366.

Who is the listed applicant for EmbedMed?

The FDA 510(k) record lists 3D Lifeprints UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmbedMed?

The FDA product code for EmbedMed is DZJ.

Other records listing 3D Lifeprints UK , Ltd. 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.

K221943EmbedMed

Related Devices (Code: DZJ)

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah Cmf K230276TECHFIT DISRP® SystemTechfit Digital Surgery K223024MedCAD AccuPlan SystemMedcad

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.