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FDA 510(k)

MAXMORESPINE TOM STICK

K-Number: K083552 · 2009-10-09

ApplicantHoogland Spine Products, GmbH
Decision Date2009-10-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXMORESPINE TOM STICK is the device name listed in this FDA 510(k) record. The listed applicant is Hoogland Spine Products, GmbH. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K083552. 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 MAXMORESPINE TOM STICK?

MAXMORESPINE TOM STICK is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Hoogland Spine Products, GmbH. The 510(k) number is K083552.

When did MAXMORESPINE TOM STICK receive FDA 510(k) clearance?

MAXMORESPINE TOM STICK received FDA 510(k) clearance on 2009-10-09, under 510(k) number K083552.

Who is the listed applicant for MAXMORESPINE TOM STICK?

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

What is the FDA product code for MAXMORESPINE TOM STICK?

The FDA product code for MAXMORESPINE TOM STICK is HRX.

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 Hoogland Spine Products, GmbH 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.

K211173maxmorespine Bipolar ElectrodesK090132MAXMORESPINE SPINAL SYSTEM

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

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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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