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FDA 510(k)

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM

K-Number: K101939 · 2010-10-07

ApplicantMerete Medical GmbH
Decision Date2010-10-07
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Merete Medical GmbH. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K101939. 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 OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM?

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Merete Medical GmbH. The 510(k) number is K101939.

When did OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM receive FDA 510(k) clearance?

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM received FDA 510(k) clearance on 2010-10-07, under 510(k) number K101939.

Who is the listed applicant for OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM?

The FDA 510(k) record lists Merete Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM?

The FDA product code for OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM 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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