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FDA 510(k)

NORMED TITANIUM MINIPLATE SYSTEM

K-Number: K931539 · 1994-07-05

ApplicantNormed Medizin-Technik GmbH
Decision Date1994-07-05
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORMED TITANIUM MINIPLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Normed Medizin-Technik GmbH. It received FDA 510(k) clearance on 1994-07-05 under 510(k) number K931539. 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 NORMED TITANIUM MINIPLATE SYSTEM?

NORMED TITANIUM MINIPLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-05. The listed applicant is Normed Medizin-Technik GmbH. The 510(k) number is K931539.

When did NORMED TITANIUM MINIPLATE SYSTEM receive FDA 510(k) clearance?

NORMED TITANIUM MINIPLATE SYSTEM received FDA 510(k) clearance on 1994-07-05, under 510(k) number K931539.

Who is the listed applicant for NORMED TITANIUM MINIPLATE SYSTEM?

The FDA 510(k) record lists Normed Medizin-Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMED TITANIUM MINIPLATE SYSTEM?

The FDA product code for NORMED TITANIUM MINIPLATE SYSTEM is JEY.

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Other records listing Normed Medizin-Technik GmbH 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.

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Official Source

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