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FDA 510(k)

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

K-Number: K103128 · 2011-02-23

ApplicantCadwell Lab, Inc.
Decision Date2011-02-23
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Lab, Inc.. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K103128. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,?

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Cadwell Lab, Inc.. The 510(k) number is K103128.

When did CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, receive FDA 510(k) clearance?

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, received FDA 510(k) clearance on 2011-02-23, under 510(k) number K103128.

Who is the listed applicant for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,?

The FDA 510(k) record lists Cadwell Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,?

The FDA product code for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, is ETN.

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Official Source

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