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FDA 510(k)

SKELETAL DYNAMICS STERILIZATION TRAYS

K-Number: K102103 · 2010-12-07

ApplicantSkeletal Dynamics, LLC
Decision Date2010-12-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKELETAL DYNAMICS STERILIZATION TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2010-12-07 under 510(k) number K102103. 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 SKELETAL DYNAMICS STERILIZATION TRAYS?

SKELETAL DYNAMICS STERILIZATION TRAYS is a medical device that received FDA 510(k) clearance on 2010-12-07. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K102103.

When did SKELETAL DYNAMICS STERILIZATION TRAYS receive FDA 510(k) clearance?

SKELETAL DYNAMICS STERILIZATION TRAYS received FDA 510(k) clearance on 2010-12-07, under 510(k) number K102103.

Who is the listed applicant for SKELETAL DYNAMICS STERILIZATION TRAYS?

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

What is the FDA product code for SKELETAL DYNAMICS STERILIZATION TRAYS?

The FDA product code for SKELETAL DYNAMICS STERILIZATION TRAYS is KCT.

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Related Devices (Code: KCT)

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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

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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