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FDA 510(k)

In2Bones Fracture and Correction System

K-Number: K170518 · 2017-07-14

ApplicantIn2bones USA, LLC
Decision Date2017-07-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

In2Bones Fracture and Correction 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 2017-07-14 under 510(k) number K170518. 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 In2Bones Fracture and Correction System?

In2Bones Fracture and Correction System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is In2bones USA, LLC. The 510(k) number is K170518.

When did In2Bones Fracture and Correction System receive FDA 510(k) clearance?

In2Bones Fracture and Correction System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K170518.

Who is the listed applicant for In2Bones Fracture and Correction 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 In2Bones Fracture and Correction System?

The FDA product code for In2Bones Fracture and Correction System is 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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