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FDA 510(k)

COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)

K-Number: K111746 · 2011-12-15

ApplicantBiomet, Inc.
Decision Date2011-12-15
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K111746. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)?

COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Biomet, Inc.. The 510(k) number is K111746.

When did COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) receive FDA 510(k) clearance?

COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) received FDA 510(k) clearance on 2011-12-15, under 510(k) number K111746.

Who is the listed applicant for COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)?

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

What is the FDA product code for COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)?

The FDA product code for COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) is KWT.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KWT)

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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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