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FDA 510(k)

CALIBRATED TISSUE GRAFT PRESS

K-Number: K822368 · 1982-09-09

ApplicantTreace Medical, Inc.
Decision Date1982-09-09
Product CodeJYW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CALIBRATED TISSUE GRAFT PRESS 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 1982-09-09 under 510(k) number K822368. The device is classified under product code JYW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATED TISSUE GRAFT PRESS?

CALIBRATED TISSUE GRAFT PRESS is a medical device that received FDA 510(k) clearance on 1982-09-09. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822368.

When did CALIBRATED TISSUE GRAFT PRESS receive FDA 510(k) clearance?

CALIBRATED TISSUE GRAFT PRESS received FDA 510(k) clearance on 1982-09-09, under 510(k) number K822368.

Who is the listed applicant for CALIBRATED TISSUE GRAFT PRESS?

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

What is the FDA product code for CALIBRATED TISSUE GRAFT PRESS?

The FDA product code for CALIBRATED TISSUE GRAFT PRESS is JYW.

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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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