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)

Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

K-Number: K182084 · 2020-11-04

ApplicantSweden & Martina S.P.A.
Decision Date2020-11-04
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K182084. 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 Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K182084.

When did Sweden & Martina Surgical Tray (Model ZSHORTY-INT) receive FDA 510(k) clearance?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) received FDA 510(k) clearance on 2020-11-04, under 510(k) number K182084.

Who is the listed applicant for Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

The FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is KCT.

Other records listing Sweden & Martina S.P.A. 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.

K222640Sweden & Martina Surgical TraysK180365PRAMA White Implant SystemsK161989PREMIUM Implant Systems SHELTA Implant SystemsK172560PREMIUM ONE Implant SystemsK162028PREMIUM - SHELTA Prosthetic ComponentsK162004PREMIUM Implant Systems SHELTA Implant Systems

View all 7 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.

↑