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FDA 510(k)

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates

K-Number: K183011 · 2019-01-10

ApplicantAdditive Orthopaedics
Decision Date2019-01-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is a medical device manufactured by Additive Orthopaedics. It received FDA 510(k) clearance on 2019-01-10 under approval 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. It is manufactured by Additive Orthopaedics. The 510(k) number is K183011.

When was Additive Orthopaedics Patient Specific 3D Locking Lattice Plates approved by the FDA?

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

What company makes Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is manufactured by Additive Orthopaedics.

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.

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Related PubMed Literature

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) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

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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.

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