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FDA 510(k)

PEDIATRIC CANNULATED OSTEOTOMY PLATES

K-Number: K983967 · 1998-12-16

ApplicantBiomet, Inc.
Decision Date1998-12-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC CANNULATED OSTEOTOMY PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983967. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC CANNULATED OSTEOTOMY PLATES?

PEDIATRIC CANNULATED OSTEOTOMY PLATES is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Biomet, Inc.. The 510(k) number is K983967.

When did PEDIATRIC CANNULATED OSTEOTOMY PLATES receive FDA 510(k) clearance?

PEDIATRIC CANNULATED OSTEOTOMY PLATES received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983967.

Who is the listed applicant for PEDIATRIC CANNULATED OSTEOTOMY PLATES?

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 CANNULATED OSTEOTOMY PLATES?

The FDA product code for PEDIATRIC CANNULATED OSTEOTOMY PLATES is HRS.

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Related Devices (Code: HRS)

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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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