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FDA 510(k)

TOTAL

K-Number: K822367 · 1982-09-07

ApplicantTreace Medical, Inc.
Decision Date1982-09-07
Product CodeLBN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TOTAL 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 1982-09-07 under 510(k) number K822367. The device is classified under product code LBN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL?

TOTAL is a medical device that received FDA 510(k) clearance on 1982-09-07. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822367.

When did TOTAL receive FDA 510(k) clearance?

TOTAL received FDA 510(k) clearance on 1982-09-07, under 510(k) number K822367.

Who is the listed applicant for TOTAL?

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 TOTAL?

The FDA product code for TOTAL is LBN.

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Related PubMed Literature

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.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 41839575A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery ()PMID: 41209898Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty.Cureus ()PMID: 39748246Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle.Expert review of medical devices ()

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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