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FDA 510(k)

NEON SYSTEM

K-Number: K113346 · 2012-02-28

ApplicantUlrich GmbH & Co. KG
Decision Date2012-02-28
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2012-02-28 under 510(k) number K113346. 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 NEON SYSTEM?

NEON SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-28. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K113346.

When did NEON SYSTEM receive FDA 510(k) clearance?

NEON SYSTEM received FDA 510(k) clearance on 2012-02-28, under 510(k) number K113346.

Who is the listed applicant for NEON SYSTEM?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEON SYSTEM?

The FDA product code for NEON SYSTEM is KWP.

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Other records listing Ulrich GmbH & Co. KG 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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