Inion BioRestore

FDA 510(k) K191764 · Inion OY

Substantially Equivalent

510(k) numberK191764

Submission

Device name
Inion BioRestore
Applicant
Inion OY
Tampere, FI
Received
July 1, 2019
Decision date
July 31, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

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K203105Inion CompressOn ScrewHWC · Traditional 01/13/2021SE
K151360Inion Spinal Graft Containment SystemOJB · Traditional 10/06/2015SESU
K133932Inion FreedompinHTY · Traditional 04/11/2014SE
K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)HWC · Traditional 02/27/2013SE
K122890Inion CPS Orbital PlatesJEY · Traditional 01/29/2013SE
K090177Inion Biorestore Biodegradable Bone Graft SubstituteMQV · Special 02/20/2009SE
K071810Inion Spinal Graft Containment SystemOJB · Traditional 07/11/2008SESU
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Questions and answers

When was Inion BioRestore cleared by the FDA?

Inion BioRestore (K191764) received a 510(k) decision of Substantially Equivalent on July 31, 2019, 30 days after the submission was received.

What is the product code of K191764?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.