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FDA 510(k)

Southern Implants Instrument Trays

K-Number: K210923 · 2022-03-02

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2022-03-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Southern Implants Instrument Trays is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K210923. 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 Southern Implants Instrument Trays?

Southern Implants Instrument Trays is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K210923.

When did Southern Implants Instrument Trays receive FDA 510(k) clearance?

Southern Implants Instrument Trays received FDA 510(k) clearance on 2022-03-02, under 510(k) number K210923.

Who is the listed applicant for Southern Implants Instrument Trays?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Southern Implants Instrument Trays?

The FDA product code for Southern Implants Instrument Trays is KCT.

Other records listing Southern Implants (Pty), Ltd. as applicant

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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.

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