Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Inion CompressOn Screw

K-Number: K203105 · 2021-01-13

ApplicantInion OY
Decision Date2021-01-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Inion CompressOn Screw is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K203105. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inion CompressOn Screw?

Inion CompressOn Screw is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Inion OY. The 510(k) number is K203105.

When did Inion CompressOn Screw receive FDA 510(k) clearance?

Inion CompressOn Screw received FDA 510(k) clearance on 2021-01-13, under 510(k) number K203105.

Who is the listed applicant for Inion CompressOn Screw?

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 CompressOn Screw?

The FDA product code for Inion CompressOn Screw is HWC. This falls under the Cardiovascular category.

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 SystemK191764Inion BioRestore

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.

↑