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FDA 510(k)

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

K-Number: K051821 · 2005-11-25

ApplicantInion , Ltd.
Decision Date2005-11-25
Product CodeOJB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2005-11-25 under 510(k) number K051821. The device is classified under product code OJB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM?

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-25. The listed applicant is Inion , Ltd.. The 510(k) number is K051821.

When did INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM receive FDA 510(k) clearance?

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM received FDA 510(k) clearance on 2005-11-25, under 510(k) number K051821.

Who is the listed applicant for INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM?

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 S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM?

The FDA product code for INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM is OJB.

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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 SYSTEMK063410INION CPS/OTPS FREEDOMPLATEK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATEK052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

View all 23 devices →

Related Devices (Code: OJB)

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 SYSTEMInion , Ltd.

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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