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FDA 510(k)

Supplemental Instrument Trays

K-Number: K170939 · 2017-08-08

ApplicantNuvasive Specialized Orthopedics, Incorporated
Decision Date2017-08-08
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Supplemental Instrument Trays is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K170939. 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 Supplemental Instrument Trays?

Supplemental Instrument Trays is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K170939.

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

Supplemental Instrument Trays received FDA 510(k) clearance on 2017-08-08, under 510(k) number K170939.

Who is the listed applicant for Supplemental Instrument Trays?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Supplemental Instrument Trays?

The FDA product code for Supplemental Instrument Trays is KCT.

Other records listing Nuvasive Specialized Orthopedics, Incorporated 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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