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FDA 510(k)

NUVASIVE VUEPOINT OCT SYSTEM

K-Number: K093319 · 2010-06-23

ApplicantNuvasive, Inc.
Decision Date2010-06-23
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE VUEPOINT OCT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K093319. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE VUEPOINT OCT SYSTEM?

NUVASIVE VUEPOINT OCT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Nuvasive, Inc.. The 510(k) number is K093319.

When did NUVASIVE VUEPOINT OCT SYSTEM receive FDA 510(k) clearance?

NUVASIVE VUEPOINT OCT SYSTEM received FDA 510(k) clearance on 2010-06-23, under 510(k) number K093319.

Who is the listed applicant for NUVASIVE VUEPOINT OCT SYSTEM?

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

What is the FDA product code for NUVASIVE VUEPOINT OCT SYSTEM?

The FDA product code for NUVASIVE VUEPOINT OCT SYSTEM is KWP.

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Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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