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FDA 510(k)

PEDIATRIC FIXATION RODS

K-Number: K000764 · 2000-04-06

ApplicantBiomet, Inc.
Decision Date2000-04-06
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC FIXATION RODS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-04-06 under 510(k) number K000764. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC FIXATION RODS?

PEDIATRIC FIXATION RODS is a medical device that received FDA 510(k) clearance on 2000-04-06. The listed applicant is Biomet, Inc.. The 510(k) number is K000764.

When did PEDIATRIC FIXATION RODS receive FDA 510(k) clearance?

PEDIATRIC FIXATION RODS received FDA 510(k) clearance on 2000-04-06, under 510(k) number K000764.

Who is the listed applicant for PEDIATRIC FIXATION RODS?

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 PEDIATRIC FIXATION RODS?

The FDA product code for PEDIATRIC FIXATION RODS is JDS.

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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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