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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 the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2024-05-24 under 510(k) 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. The listed applicant is In2bones USA, LLC. The 510(k) number is K233089.

When did NeoSpan® Compression Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for NeoSpan® Compression Implant 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 NeoSpan® Compression Implant System?

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

Other records listing In2bones USA, LLC as applicant

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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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