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FDA 510(k)

SYNTHES SCOUT VESSEL GUARD

K-Number: K103558 · 2011-02-18

ApplicantSynthes Spine
Decision Date2011-02-18
Product CodeOMR
Advisory CommitteeCV
DecisionUnknown

Device Summary

SYNTHES SCOUT VESSEL GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2011-02-18 under 510(k) number K103558. The device is classified under product code OMR. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SYNTHES SCOUT VESSEL GUARD?

SYNTHES SCOUT VESSEL GUARD is a medical device that received FDA 510(k) clearance on 2011-02-18. The listed applicant is Synthes Spine. The 510(k) number is K103558.

When did SYNTHES SCOUT VESSEL GUARD receive FDA 510(k) clearance?

SYNTHES SCOUT VESSEL GUARD received FDA 510(k) clearance on 2011-02-18, under 510(k) number K103558.

Who is the listed applicant for SYNTHES SCOUT VESSEL GUARD?

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

What is the FDA product code for SYNTHES SCOUT VESSEL GUARD?

The FDA product code for SYNTHES SCOUT VESSEL GUARD is OMR.

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Other records listing Synthes Spine as applicant

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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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Related Devices (Code: OMR)

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.

K111048SYNTHES SCOUT TACK FIXATIONSynthes SpineK111137HYDROFIX VASO SHIELDMimedx Group, Inc.K101805HYDROFIX VASO SHIELDMimedx Group, Inc.K101826HYDROFIX VASO SHIELD, MODEL HVS-001-0610Mimedx Group, Inc.K100984XYLOS VESSEL GUARDXylos CorporationK100905HYDROFIX SURGICAL SHEETMimedx Group, Inc.

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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