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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 a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2019-08-08 under approval 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. It is manufactured by In2bones USA, LLC. The 510(k) number is K190385.

When was CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System approved by the FDA?

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

What company makes 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 manufactured by In2bones USA, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by In2bones USA, LLC

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Related Devices (Code: HRS)

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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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