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FDA 510(k)

SEASPINE MONOPOLAR PROBE SYSYEM

K-Number: K111671 · 2011-12-28

ApplicantSeaspine, Inc.
Decision Date2011-12-28
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SEASPINE MONOPOLAR PROBE SYSYEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2011-12-28 under 510(k) number K111671. 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 SEASPINE MONOPOLAR PROBE SYSYEM?

SEASPINE MONOPOLAR PROBE SYSYEM is a medical device that received FDA 510(k) clearance on 2011-12-28. The listed applicant is Seaspine, Inc.. The 510(k) number is K111671.

When did SEASPINE MONOPOLAR PROBE SYSYEM receive FDA 510(k) clearance?

SEASPINE MONOPOLAR PROBE SYSYEM received FDA 510(k) clearance on 2011-12-28, under 510(k) number K111671.

Who is the listed applicant for SEASPINE MONOPOLAR PROBE SYSYEM?

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

What is the FDA product code for SEASPINE MONOPOLAR PROBE SYSYEM?

The FDA product code for SEASPINE MONOPOLAR PROBE SYSYEM is ETN.

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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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