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FDA 510(k)

MODIFICATION TO STAXX FX SYSTEM

K-Number: K063606 · 2007-04-13

ApplicantSpine Wave, Inc.
Decision Date2007-04-13
Product CodeOBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO STAXX FX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K063606. The device is classified under product code OBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO STAXX FX SYSTEM?

MODIFICATION TO STAXX FX SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Spine Wave, Inc.. The 510(k) number is K063606.

When did MODIFICATION TO STAXX FX SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO STAXX FX SYSTEM received FDA 510(k) clearance on 2007-04-13, under 510(k) number K063606.

Who is the listed applicant for MODIFICATION TO STAXX FX SYSTEM?

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

What is the FDA product code for MODIFICATION TO STAXX FX SYSTEM?

The FDA product code for MODIFICATION TO STAXX FX SYSTEM is OBL.

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Other records listing Spine Wave, Inc. as applicant

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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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