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FDA 510(k)

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON

K-Number: K071107 · 2007-07-06

ApplicantZimmer, Inc.
Decision Date2007-07-06
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2007-07-06 under 510(k) number K071107. 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 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON?

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON is a medical device that received FDA 510(k) clearance on 2007-07-06. The listed applicant is Zimmer, Inc.. The 510(k) number is K071107.

When did GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON receive FDA 510(k) clearance?

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON received FDA 510(k) clearance on 2007-07-06, under 510(k) number K071107.

Who is the listed applicant for GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON?

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

What is the FDA product code for GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON?

The FDA product code for GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON is MBH.

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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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