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FDA 510(k)

ESPIN

K-Number: K120553 · 2012-08-09

ApplicantNlt Spine, Ltd.
Decision Date2012-08-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ESPIN 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 2012-08-09 under 510(k) number K120553. 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?

ESPIN is a medical device that received FDA 510(k) clearance on 2012-08-09. The listed applicant is Nlt Spine, Ltd.. The 510(k) number is K120553.

When did ESPIN receive FDA 510(k) clearance?

ESPIN received FDA 510(k) clearance on 2012-08-09, under 510(k) number K120553.

Who is the listed applicant for ESPIN?

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?

The FDA product code for ESPIN 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-VK133061ESPIN SYSTEMK130254PROW FUSIONK130057ESPINK112359PROW FUSION

View all 7 devices →

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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