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FDA 510(k)

MEC DISTAL FEMORAL BOLT

K-Number: K850403 · 1985-07-15

ApplicantPfizer, Inc.
Decision Date1985-07-15
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEC DISTAL FEMORAL BOLT is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K850403. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEC DISTAL FEMORAL BOLT?

MEC DISTAL FEMORAL BOLT is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K850403.

When did MEC DISTAL FEMORAL BOLT receive FDA 510(k) clearance?

MEC DISTAL FEMORAL BOLT received FDA 510(k) clearance on 1985-07-15, under 510(k) number K850403.

Who is the listed applicant for MEC DISTAL FEMORAL BOLT?

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 DISTAL FEMORAL BOLT?

The FDA product code for MEC DISTAL FEMORAL BOLT is KTT.

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Related Devices (Code: KTT)

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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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