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FDA 510(k)

MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL

K-Number: K972692 · 1997-09-19

ApplicantZimmer, Inc.
Decision Date1997-09-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K972692. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL?

MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Zimmer, Inc.. The 510(k) number is K972692.

When did MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL receive FDA 510(k) clearance?

MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL received FDA 510(k) clearance on 1997-09-19, under 510(k) number K972692.

Who is the listed applicant for MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL?

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

What is the FDA product code for MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL?

The FDA product code for MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL is HSB.

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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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