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FDA 510(k)

ESPIN SYSTEM

K-Number: K133061 · 2013-11-27

ApplicantNlt Spine, Ltd.
Decision Date2013-11-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ESPIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nlt Spine, Ltd.. It received FDA 510(k) clearance on 2013-11-27 under 510(k) number K133061. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPIN SYSTEM?

ESPIN SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-27. The listed applicant is Nlt Spine, Ltd.. The 510(k) number is K133061.

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

ESPIN SYSTEM received FDA 510(k) clearance on 2013-11-27, under 510(k) number K133061.

Who is the listed applicant for ESPIN SYSTEM?

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

What is the FDA product code for ESPIN SYSTEM?

The FDA product code for ESPIN SYSTEM is HRX.

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Other records listing Nlt Spine, Ltd. 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.

K153665PROW FUSION-LK153786PROW FUSION-VK130254PROW FUSIONK130057ESPINK120553ESPINK112359PROW FUSION

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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