Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iTotal Family Reusable Instrument Tray

K-Number: K170226 · 2017-10-25

ApplicantConformis, Inc.
Decision Date2017-10-25
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iTotal Family Reusable Instrument Tray is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K170226. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTotal Family Reusable Instrument Tray?

iTotal Family Reusable Instrument Tray is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Conformis, Inc.. The 510(k) number is K170226.

When did iTotal Family Reusable Instrument Tray receive FDA 510(k) clearance?

iTotal Family Reusable Instrument Tray received FDA 510(k) clearance on 2017-10-25, under 510(k) number K170226.

Who is the listed applicant for iTotal Family Reusable Instrument Tray?

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

What is the FDA product code for iTotal Family Reusable Instrument Tray?

The FDA product code for iTotal Family Reusable Instrument Tray is KCT.

Other records listing Conformis, 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.

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsK223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemK230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemK231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSK231178ACTERA™ hip systemK230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

View all 30 devices →

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑