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FDA 510(k)

RESOFIX BIOABSORBABLE EXPANSION BOLT

K-Number: K043411 · 2005-02-17

ApplicantResofix, Inc.
Decision Date2005-02-17
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESOFIX BIOABSORBABLE EXPANSION BOLT is the device name listed in this FDA 510(k) record. The listed applicant is Resofix, Inc.. It received FDA 510(k) clearance on 2005-02-17 under 510(k) number K043411. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOFIX BIOABSORBABLE EXPANSION BOLT?

RESOFIX BIOABSORBABLE EXPANSION BOLT is a medical device that received FDA 510(k) clearance on 2005-02-17. The listed applicant is Resofix, Inc.. The 510(k) number is K043411.

When did RESOFIX BIOABSORBABLE EXPANSION BOLT receive FDA 510(k) clearance?

RESOFIX BIOABSORBABLE EXPANSION BOLT received FDA 510(k) clearance on 2005-02-17, under 510(k) number K043411.

Who is the listed applicant for RESOFIX BIOABSORBABLE EXPANSION BOLT?

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

What is the FDA product code for RESOFIX BIOABSORBABLE EXPANSION BOLT?

The FDA product code for RESOFIX BIOABSORBABLE EXPANSION BOLT is HTN.

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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.

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