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FDA 510(k)

LESSRAY

K-Number: K132970 · 2013-11-29

ApplicantSaferay Spine, LLC
Decision Date2013-11-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LESSRAY is the device name listed in this FDA 510(k) record. The listed applicant is Saferay Spine, LLC. It received FDA 510(k) clearance on 2013-11-29 under 510(k) number K132970. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LESSRAY?

LESSRAY is a medical device that received FDA 510(k) clearance on 2013-11-29. The listed applicant is Saferay Spine, LLC. The 510(k) number is K132970.

When did LESSRAY receive FDA 510(k) clearance?

LESSRAY received FDA 510(k) clearance on 2013-11-29, under 510(k) number K132970.

Who is the listed applicant for LESSRAY?

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

What is the FDA product code for LESSRAY?

The FDA product code for LESSRAY is OWB.

Related Clinical Trials

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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Other records listing Saferay Spine, LLC 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.

K123226LESSRAY

Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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