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FDA 510(k)

INTRAMEDULLARY FIXATION ROD (IFS)

K-Number: K083458 · 2009-02-09

ApplicantNovalign Orthopaedics, Inc.
Decision Date2009-02-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAMEDULLARY FIXATION ROD (IFS) is the device name listed in this FDA 510(k) record. The listed applicant is Novalign Orthopaedics, Inc.. It received FDA 510(k) clearance on 2009-02-09 under 510(k) number K083458. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAMEDULLARY FIXATION ROD (IFS)?

INTRAMEDULLARY FIXATION ROD (IFS) is a medical device that received FDA 510(k) clearance on 2009-02-09. The listed applicant is Novalign Orthopaedics, Inc.. The 510(k) number is K083458.

When did INTRAMEDULLARY FIXATION ROD (IFS) receive FDA 510(k) clearance?

INTRAMEDULLARY FIXATION ROD (IFS) received FDA 510(k) clearance on 2009-02-09, under 510(k) number K083458.

Who is the listed applicant for INTRAMEDULLARY FIXATION ROD (IFS)?

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

What is the FDA product code for INTRAMEDULLARY FIXATION ROD (IFS)?

The FDA product code for INTRAMEDULLARY FIXATION ROD (IFS) is HSB.

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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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