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FDA 510(k)

INION CPS/OTPS FREEDOMPLATE

K-Number: K063410 · 2007-01-23

ApplicantInion , Ltd.
Decision Date2007-01-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION CPS/OTPS FREEDOMPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2007-01-23 under 510(k) number K063410. 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 INION CPS/OTPS FREEDOMPLATE?

INION CPS/OTPS FREEDOMPLATE is a medical device that received FDA 510(k) clearance on 2007-01-23. The listed applicant is Inion , Ltd.. The 510(k) number is K063410.

When did INION CPS/OTPS FREEDOMPLATE receive FDA 510(k) clearance?

INION CPS/OTPS FREEDOMPLATE received FDA 510(k) clearance on 2007-01-23, under 510(k) number K063410.

Who is the listed applicant for INION CPS/OTPS FREEDOMPLATE?

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

What is the FDA product code for INION CPS/OTPS FREEDOMPLATE?

The FDA product code for INION CPS/OTPS FREEDOMPLATE is HRS.

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Other records listing Inion , Ltd. 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.

K071810INION SPINAL GRAFT CONTAINMENT SYSTEMK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATEK052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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