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FDA 510(k)

MEC BROAD BONE PLATE

K-Number: K850442 · 1985-04-19

ApplicantPfizer, Inc.
Decision Date1985-04-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEC BROAD BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K850442. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEC BROAD BONE PLATE?

MEC BROAD BONE PLATE is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Pfizer, Inc.. The 510(k) number is K850442.

When did MEC BROAD BONE PLATE receive FDA 510(k) clearance?

MEC BROAD BONE PLATE received FDA 510(k) clearance on 1985-04-19, under 510(k) number K850442.

Who is the listed applicant for MEC BROAD BONE PLATE?

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

What is the FDA product code for MEC BROAD BONE PLATE?

The FDA product code for MEC BROAD BONE PLATE is HRS.

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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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