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FDA 510(k)

SCREW, BONE, MAXILLOFACIAL

K-Number: K911165 · 1991-08-20

ApplicantTekno-Medical
Decision Date1991-08-20
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCREW, BONE, MAXILLOFACIAL is the device name listed in this FDA 510(k) record. The listed applicant is Tekno-Medical. It received FDA 510(k) clearance on 1991-08-20 under 510(k) number K911165. 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 SCREW, BONE, MAXILLOFACIAL?

SCREW, BONE, MAXILLOFACIAL is a medical device that received FDA 510(k) clearance on 1991-08-20. The listed applicant is Tekno-Medical. The 510(k) number is K911165.

When did SCREW, BONE, MAXILLOFACIAL receive FDA 510(k) clearance?

SCREW, BONE, MAXILLOFACIAL received FDA 510(k) clearance on 1991-08-20, under 510(k) number K911165.

Who is the listed applicant for SCREW, BONE, MAXILLOFACIAL?

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

What is the FDA product code for SCREW, BONE, MAXILLOFACIAL?

The FDA product code for SCREW, BONE, MAXILLOFACIAL is DZL.

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Related Devices (Code: 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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