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FDA 510(k)

INION BIORESTORE

K-Number: K070784 · 2007-07-24

ApplicantInion OY
Decision Date2007-07-24
Product CodeLYC
Advisory CommitteeDE
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 2007-07-24 under 510(k) number K070784. The device is classified under product code LYC. It was reviewed by the DE 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 2007-07-24. The listed applicant is Inion OY. The 510(k) number is K070784.

When did INION BIORESTORE receive FDA 510(k) clearance?

INION BIORESTORE received FDA 510(k) clearance on 2007-07-24, under 510(k) number K070784.

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 LYC.

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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 ScrewK191764Inion BioRestoreK123672INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)K122890INION CPS ORBITAL PLATES

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Related Devices (Code: LYC)

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

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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