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FDA 510(k)

NeoSpan® Compression Implant System

K-Number: K233089 · 2024-05-24

ApplicantIn2bones USA, LLC
Decision Date2024-05-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NeoSpan® Compression Implant System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2024-05-24 under approval number K233089. 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 NeoSpan® Compression Implant System?

NeoSpan® Compression Implant System is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by In2bones USA, LLC. The 510(k) number is K233089.

When was NeoSpan® Compression Implant System approved by the FDA?

NeoSpan® Compression Implant System received FDA 510(k) clearance on 2024-05-24, under approval number K233089.

What company makes NeoSpan® Compression Implant System?

NeoSpan® Compression Implant System is manufactured by In2bones USA, LLC.

What is the FDA product code for NeoSpan® Compression Implant System?

The FDA product code for NeoSpan® Compression Implant System is HRS.

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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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