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FDA 510(k)

QUANTUM RING FIXATION SYSTEM MODEL ISF

K-Number: K101759 · 2010-10-22

ApplicantQuantum Medical Concepts, LLC
Decision Date2010-10-22
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUANTUM RING FIXATION SYSTEM MODEL ISF is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Medical Concepts, LLC. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K101759. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM RING FIXATION SYSTEM MODEL ISF?

QUANTUM RING FIXATION SYSTEM MODEL ISF is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Quantum Medical Concepts, LLC. The 510(k) number is K101759.

When did QUANTUM RING FIXATION SYSTEM MODEL ISF receive FDA 510(k) clearance?

QUANTUM RING FIXATION SYSTEM MODEL ISF received FDA 510(k) clearance on 2010-10-22, under 510(k) number K101759.

Who is the listed applicant for QUANTUM RING FIXATION SYSTEM MODEL ISF?

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

What is the FDA product code for QUANTUM RING FIXATION SYSTEM MODEL ISF?

The FDA product code for QUANTUM RING FIXATION SYSTEM MODEL ISF is KTT.

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 Quantum Medical Concepts, 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.

K111993FRAMEWALKER

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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