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FDA 510(k)

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

K-Number: K100497 · 2010-06-21

ApplicantN.M.B. Medical Applications, Ltd.
Decision Date2010-06-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is N.M.B. Medical Applications, Ltd.. It received FDA 510(k) clearance on 2010-06-21 under 510(k) number K100497. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)?

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) is a medical device that received FDA 510(k) clearance on 2010-06-21. The listed applicant is N.M.B. Medical Applications, Ltd.. The 510(k) number is K100497.

When did QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) receive FDA 510(k) clearance?

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) received FDA 510(k) clearance on 2010-06-21, under 510(k) number K100497.

Who is the listed applicant for QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)?

The FDA 510(k) record lists N.M.B. Medical Applications, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)?

The FDA product code for QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) is HSB.

Related Clinical Trials

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Other records listing N.M.B. Medical Applications, 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.

K102597PICCOLO COMPOSITE PLATE SYSTEMK102369PICCOLO COMPOSITE NAILING SYSTEMK091425QUANTUM M COMPOSITE NAILING SYSTEM

Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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