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FDA 510(k)

NeoSpan Compression Staple Impant w/instruments

K-Number: K161426 · 2016-10-24

ApplicantIn2bones USA, LLC
Decision Date2016-10-24
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NeoSpan Compression Staple Impant w/instruments is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161426. 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 NeoSpan Compression Staple Impant w/instruments?

NeoSpan Compression Staple Impant w/instruments is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is In2bones USA, LLC. The 510(k) number is K161426.

When did NeoSpan Compression Staple Impant w/instruments receive FDA 510(k) clearance?

NeoSpan Compression Staple Impant w/instruments received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161426.

Who is the listed applicant for NeoSpan Compression Staple Impant w/instruments?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoSpan Compression Staple Impant w/instruments?

The FDA product code for NeoSpan Compression Staple Impant w/instruments is JDR.

Other records listing In2bones USA, 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.

K261154CoLink® & CoLag® Non-Sterile ScrewsK241387CoLink NeoFuse MIS Plating System (see attached parts list)K233089NeoSpan® Compression Implant SystemK231236IBS-B MIS Beveled Screw SystemK213698CoLink PCR Plating SystemK220260Hercules Syndesmosis Implant System

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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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