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FDA 510(k)

23 MM SINGLE-PEG PATELLA COMPONENT

K-Number: K061340 · 2006-09-25

ApplicantBiomet Manufacturing, Inc.
Decision Date2006-09-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

23 MM SINGLE-PEG PATELLA COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K061340. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 23 MM SINGLE-PEG PATELLA COMPONENT?

23 MM SINGLE-PEG PATELLA COMPONENT is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K061340.

When did 23 MM SINGLE-PEG PATELLA COMPONENT receive FDA 510(k) clearance?

23 MM SINGLE-PEG PATELLA COMPONENT received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061340.

Who is the listed applicant for 23 MM SINGLE-PEG PATELLA COMPONENT?

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

What is the FDA product code for 23 MM SINGLE-PEG PATELLA COMPONENT?

The FDA product code for 23 MM SINGLE-PEG PATELLA COMPONENT is JWH.

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Other records listing Biomet Manufacturing, Inc. as applicant

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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEM

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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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