FDA 510(k)

ICON (TM) MODULAR PEDICLE SCREW SYSTEM

K-Number: K111448 · 2012-02-16

Decision Date2012-02-16

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ICON (TM) MODULAR PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K111448. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICON (TM) MODULAR PEDICLE SCREW SYSTEM?

ICON (TM) MODULAR PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Orthofix, Inc.. The 510(k) number is K111448.

When did ICON (TM) MODULAR PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

ICON (TM) MODULAR PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2012-02-16, under 510(k) number K111448.

Who is the listed applicant for ICON (TM) MODULAR PEDICLE SCREW SYSTEM?

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

What is the FDA product code for ICON (TM) MODULAR PEDICLE SCREW SYSTEM?

The FDA product code for ICON (TM) MODULAR PEDICLE SCREW SYSTEM is NKB.

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Related Devices (Code: NKB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.