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FDA 510(k)

MALLET, SURGICAL

K-Number: K882349 · 1988-06-23

ApplicantTreace Medical, Inc.
Decision Date1988-06-23
Product CodeHXL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MALLET, SURGICAL 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 1988-06-23 under 510(k) number K882349. The device is classified under product code HXL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLET, SURGICAL?

MALLET, SURGICAL is a medical device that received FDA 510(k) clearance on 1988-06-23. The listed applicant is Treace Medical, Inc.. The 510(k) number is K882349.

When did MALLET, SURGICAL receive FDA 510(k) clearance?

MALLET, SURGICAL received FDA 510(k) clearance on 1988-06-23, under 510(k) number K882349.

Who is the listed applicant for MALLET, SURGICAL?

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 MALLET, SURGICAL?

The FDA product code for MALLET, SURGICAL is HXL.

Related Clinical Trials

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.

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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 PORPK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERSK871706OPTHA PREP

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Related Devices (Code: HXL)

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.

K872209ARTHROPLASTY MALLETNew England Surgical Instrument Corp.K871195MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.Military Engineering, Inc.

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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