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FDA 510(k)

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples

K-Number: K230724 · 2023-12-04

ApplicantNovastep
Decision Date2023-12-04
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K230724. 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 arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Novastep. The 510(k) number is K230724.

When did arcad® 2.0 Duo & Quadro osteosynthesis compressive staples receive FDA 510(k) clearance?

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples received FDA 510(k) clearance on 2023-12-04, under 510(k) number K230724.

Who is the listed applicant for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

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

What is the FDA product code for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

The FDA product code for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is JDR.

Other records listing Novastep 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.

K223468Nexis® compressive screwsK192356Airlock Centrolock Osteosynthesis Implant System

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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