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FDA 510(k)

MODIFICATION TO CAPSURE PS SYSTEM

K-Number: K100122 · 2010-02-12

ApplicantSpine Wave, Inc.
Decision Date2010-02-12
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CAPSURE PS 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 2010-02-12 under 510(k) number K100122. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO CAPSURE PS SYSTEM?

MODIFICATION TO CAPSURE PS SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Spine Wave, Inc.. The 510(k) number is K100122.

When did MODIFICATION TO CAPSURE PS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO CAPSURE PS SYSTEM received FDA 510(k) clearance on 2010-02-12, under 510(k) number K100122.

Who is the listed applicant for MODIFICATION TO CAPSURE PS 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 CAPSURE PS SYSTEM?

The FDA product code for MODIFICATION TO CAPSURE PS SYSTEM is MNH. This falls under the ENT category.

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Other records listing Spine Wave, Inc. as applicant

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Related Devices (Code: MNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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