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FDA 510(k)

SKY BONE EXPANDER SYSTEM

K-Number: K034037 · 2004-01-28

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2004-01-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SKY BONE EXPANDER SYSTEM 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 2004-01-28 under 510(k) number K034037. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKY BONE EXPANDER SYSTEM?

SKY BONE EXPANDER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-28. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K034037.

When did SKY BONE EXPANDER SYSTEM receive FDA 510(k) clearance?

SKY BONE EXPANDER SYSTEM received FDA 510(k) clearance on 2004-01-28, under 510(k) number K034037.

Who is the listed applicant for SKY BONE EXPANDER SYSTEM?

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 SKY BONE EXPANDER SYSTEM?

The FDA product code for SKY BONE EXPANDER SYSTEM is HRX.

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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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