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FDA 510(k)

CONSENSUS KNEE SYSTEM

K-Number: K110950 · 2011-06-27

ApplicantConsensus Orthopedics, Inc.
Decision Date2011-06-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2011-06-27 under 510(k) number K110950. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONSENSUS KNEE SYSTEM?

CONSENSUS KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-27. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K110950.

When did CONSENSUS KNEE SYSTEM receive FDA 510(k) clearance?

CONSENSUS KNEE SYSTEM received FDA 510(k) clearance on 2011-06-27, under 510(k) number K110950.

Who is the listed applicant for CONSENSUS KNEE SYSTEM?

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

What is the FDA product code for CONSENSUS KNEE SYSTEM?

The FDA product code for CONSENSUS KNEE SYSTEM is MBH.

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Other records listing Consensus Orthopedics, Inc. as applicant

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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