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FDA 510(k)

Additive Orthopaedics Patient Specific 3D Printed Bone Segments

K-Number: K180239 · 2018-05-16

ApplicantAdditive Orthopaedics, LLC
Decision Date2018-05-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180239. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K180239.

When did Additive Orthopaedics Patient Specific 3D Printed Bone Segments receive FDA 510(k) clearance?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180239.

Who is the listed applicant for Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

The FDA 510(k) record lists Additive Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

The FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments is HRS.

Related Clinical Trials

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NCT07628010Modern Methods of Treatment and Diagnosis of Patients With Injuries and Diseases of the Musculoskeletal SystemACTIVE_NOT_RECRUITING

Other records listing Additive Orthopaedics, LLC 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.

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker 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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