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FDA 510(k)

VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY

K-Number: K100887 · 2010-08-09

ApplicantTag Medical Products
Decision Date2010-08-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Tag Medical Products. It received FDA 510(k) clearance on 2010-08-09 under 510(k) number K100887. 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 VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY?

VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2010-08-09. The listed applicant is Tag Medical Products. The 510(k) number is K100887.

When did VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY receive FDA 510(k) clearance?

VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY received FDA 510(k) clearance on 2010-08-09, under 510(k) number K100887.

Who is the listed applicant for VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY?

The FDA 510(k) record lists Tag Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY?

The FDA product code for VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY is KCT.

Related Clinical Trials

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Other records listing Tag Medical Products 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.

K091694MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)K083096LATARJET CORTICAL SCREW SETK020705SIIS#1 TISSUE SUSPENSION SYSTEM

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.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.

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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