FDA 510(k)

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00

K-Number: K063729 · 2007-08-21

Decision Date2007-08-21

Product CodeGXZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2007-08-21 under 510(k) number K063729. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00?

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 is a medical device that received FDA 510(k) clearance on 2007-08-21. The listed applicant is Technomed Europe. The 510(k) number is K063729.

When did DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 receive FDA 510(k) clearance?

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 received FDA 510(k) clearance on 2007-08-21, under 510(k) number K063729.

Who is the listed applicant for DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00?

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

What is the FDA product code for DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00?

The FDA product code for DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 is GXZ.

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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.