FDA 510(k)

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates

K-Number: K183011 · 2019-01-10

Decision Date2019-01-10

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K183011. 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 Locking Lattice Plates?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Additive Orthopaedics. The 510(k) number is K183011.

When did Additive Orthopaedics Patient Specific 3D Locking Lattice Plates receive FDA 510(k) clearance?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates received FDA 510(k) clearance on 2019-01-10, under 510(k) number K183011.

Who is the listed applicant for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

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

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

The FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is HRS.

Other records listing Additive Orthopaedics 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.

K211076Patient Specific Marking Guides K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments K163593Additive Orthopaedics Bunion System K170214Additive Orthopaedics Locking Lattice Plate K153207Additive Orthopaedics Bone Wedge System K160264Additive Orthopaedics Hammertoe Correction System

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Related Devices (Code: HRS)

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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.