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FDA 510(k)

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System

K-Number: K190385 · 2019-08-08

ApplicantIn2bones USA, LLC
Decision Date2019-08-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System 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 2019-08-08 under 510(k) number K190385. 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 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is a medical device that received FDA 510(k) clearance on 2019-08-08. The listed applicant is In2bones USA, LLC. The 510(k) number is K190385.

When did CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System receive FDA 510(k) clearance?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System received FDA 510(k) clearance on 2019-08-08, under 510(k) number K190385.

Who is the listed applicant for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

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 CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is HRS.

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Other records listing In2bones USA, LLC as applicant

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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