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FDA 510(k)

CONFIDENCE HIGH VISCOSITY BONE CEMENT

K-Number: K060300 · 2006-06-21

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2006-06-21
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFIDENCE HIGH VISCOSITY BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2006-06-21 under 510(k) number K060300. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDENCE HIGH VISCOSITY BONE CEMENT?

CONFIDENCE HIGH VISCOSITY BONE CEMENT is a medical device that received FDA 510(k) clearance on 2006-06-21. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K060300.

When did CONFIDENCE HIGH VISCOSITY BONE CEMENT receive FDA 510(k) clearance?

CONFIDENCE HIGH VISCOSITY BONE CEMENT received FDA 510(k) clearance on 2006-06-21, under 510(k) number K060300.

Who is the listed applicant for CONFIDENCE HIGH VISCOSITY BONE CEMENT?

The FDA 510(k) record lists Disc-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONFIDENCE HIGH VISCOSITY BONE CEMENT?

The FDA product code for CONFIDENCE HIGH VISCOSITY BONE CEMENT is NDN.

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Other records listing Disc-O-Tech Medical Technologies, Ltd. as applicant

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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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