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FDA 510(k)

Orbitum Bone Staple Implant, X and VI

K-Number: K173693 · 2018-02-23

ApplicantOrthovestments, LLC
Decision Date2018-02-23
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orbitum Bone Staple Implant, X and VI is the device name listed in this FDA 510(k) record. The listed applicant is Orthovestments, LLC. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173693. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orbitum Bone Staple Implant, X and VI?

Orbitum Bone Staple Implant, X and VI is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Orthovestments, LLC. The 510(k) number is K173693.

When did Orbitum Bone Staple Implant, X and VI receive FDA 510(k) clearance?

Orbitum Bone Staple Implant, X and VI received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173693.

Who is the listed applicant for Orbitum Bone Staple Implant, X and VI?

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

What is the FDA product code for Orbitum Bone Staple Implant, X and VI?

The FDA product code for Orbitum Bone Staple Implant, X and VI is JDR.

Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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