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FDA 510(k)

20-HOLE ADAPTATION PLATE

K-Number: K981070 · 1998-05-20

ApplicantBiomet, Inc.
Decision Date1998-05-20
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

20-HOLE ADAPTATION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K981070. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20-HOLE ADAPTATION PLATE?

20-HOLE ADAPTATION PLATE is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Biomet, Inc.. The 510(k) number is K981070.

When did 20-HOLE ADAPTATION PLATE receive FDA 510(k) clearance?

20-HOLE ADAPTATION PLATE received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981070.

Who is the listed applicant for 20-HOLE ADAPTATION PLATE?

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 20-HOLE ADAPTATION PLATE?

The FDA product code for 20-HOLE ADAPTATION PLATE is JEY.

Related Clinical Trials

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.

Other records listing Biomet, 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.

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Related Devices (Code: JEY)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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