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FDA 510(k)

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT

K-Number: K003131 · 2000-11-02

ApplicantBiomet, Inc.
Decision Date2000-11-02
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-11-02 under 510(k) number K003131. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT?

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT is a medical device that received FDA 510(k) clearance on 2000-11-02. The listed applicant is Biomet, Inc.. The 510(k) number is K003131.

When did MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT receive FDA 510(k) clearance?

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT received FDA 510(k) clearance on 2000-11-02, under 510(k) number K003131.

Who is the listed applicant for MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT?

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 MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT?

The FDA product code for MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT is JDW.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: JDW)

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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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