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FDA 510(k)

Inion BioRestore

K-Number: K191764 · 2019-07-31

ApplicantInion OY
Decision Date2019-07-31
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Inion BioRestore is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191764. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inion BioRestore?

Inion BioRestore is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Inion OY. The 510(k) number is K191764.

When did Inion BioRestore receive FDA 510(k) clearance?

Inion BioRestore received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191764.

Who is the listed applicant for Inion BioRestore?

The FDA 510(k) record lists Inion OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inion BioRestore?

The FDA product code for Inion BioRestore is MQV.

Related Clinical Trials

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.

NCT07473947Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent PatientsRECRUITING

Other records listing Inion OY as applicant

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.

K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemK251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemK203105Inion CompressOn Screw

Related Devices (Code: MQV)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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