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FDA 510(k)

SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

K-Number: K040612 · 2004-06-17

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2004-06-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SKY BONE EXPANDER SYSTEM (SKY 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 2004-06-17 under 510(k) number K040612. 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 SYSTEM)?

SKY BONE EXPANDER SYSTEM (SKY SYSTEM) is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K040612.

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

SKY BONE EXPANDER SYSTEM (SKY SYSTEM) received FDA 510(k) clearance on 2004-06-17, under 510(k) number K040612.

Who is the listed applicant for SKY BONE EXPANDER SYSTEM (SKY 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 (SKY SYSTEM)?

The FDA product code for SKY BONE EXPANDER SYSTEM (SKY 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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