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FDA 510(k)

SYNTHES VECTRA-T SYSTEM

K-Number: K051665 · 2005-09-09

ApplicantSynthes Spine
Decision Date2005-09-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES VECTRA-T SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K051665. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES VECTRA-T SYSTEM?

SYNTHES VECTRA-T SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Synthes Spine. The 510(k) number is K051665.

When did SYNTHES VECTRA-T SYSTEM receive FDA 510(k) clearance?

SYNTHES VECTRA-T SYSTEM received FDA 510(k) clearance on 2005-09-09, under 510(k) number K051665.

Who is the listed applicant for SYNTHES VECTRA-T SYSTEM?

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 VECTRA-T SYSTEM?

The FDA product code for SYNTHES VECTRA-T SYSTEM is KWQ.

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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: KWQ)

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.

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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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