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FDA 510(k)

LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM

K-Number: K761228 · 1976-12-15

ApplicantHowmedica Corp.
Decision Date1976-12-15
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1976-12-15 under 510(k) number K761228. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM?

LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1976-12-15. The listed applicant is Howmedica Corp.. The 510(k) number is K761228.

When did LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM receive FDA 510(k) clearance?

LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM received FDA 510(k) clearance on 1976-12-15, under 510(k) number K761228.

Who is the listed applicant for LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM?

The FDA product code for LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM is DZL.

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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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