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FDA 510(k)

INTRABLOCK BIOBALL HIP SYSTEM (IBS)

K-Number: K123619 · 2013-05-24

ApplicantMerete Medical GmbH
Decision Date2013-05-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRABLOCK BIOBALL HIP SYSTEM (IBS) 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 2013-05-24 under 510(k) number K123619. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRABLOCK BIOBALL HIP SYSTEM (IBS)?

INTRABLOCK BIOBALL HIP SYSTEM (IBS) is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Merete Medical GmbH. The 510(k) number is K123619.

When did INTRABLOCK BIOBALL HIP SYSTEM (IBS) receive FDA 510(k) clearance?

INTRABLOCK BIOBALL HIP SYSTEM (IBS) received FDA 510(k) clearance on 2013-05-24, under 510(k) number K123619.

Who is the listed applicant for INTRABLOCK BIOBALL HIP SYSTEM (IBS)?

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 INTRABLOCK BIOBALL HIP SYSTEM (IBS)?

The FDA product code for INTRABLOCK BIOBALL HIP SYSTEM (IBS) is LZO.

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Related Devices (Code: LZO)

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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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