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FDA 510(k)

TREACE MEDICAL FOAM INSTRUMENT PAD

K-Number: K861914 · 1986-06-06

ApplicantTreace Medical, Inc.
Decision Date1986-06-06
Product Code
DecisionSubstantially Equivalent

Device Summary

TREACE MEDICAL FOAM INSTRUMENT PAD is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1986-06-06 under 510(k) number K861914. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREACE MEDICAL FOAM INSTRUMENT PAD?

TREACE MEDICAL FOAM INSTRUMENT PAD is a medical device that received FDA 510(k) clearance on 1986-06-06. The listed applicant is Treace Medical, Inc.. The 510(k) number is K861914.

When did TREACE MEDICAL FOAM INSTRUMENT PAD receive FDA 510(k) clearance?

TREACE MEDICAL FOAM INSTRUMENT PAD received FDA 510(k) clearance on 1986-06-06, under 510(k) number K861914.

Who is the listed applicant for TREACE MEDICAL FOAM INSTRUMENT PAD?

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

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Other records listing Treace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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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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