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FDA 510(k)

FRAMEWALKER

K-Number: K111993 · 2011-10-24

ApplicantQuantum Medical Concepts, LLC
Decision Date2011-10-24
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRAMEWALKER 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 2011-10-24 under 510(k) number K111993. 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 FRAMEWALKER?

FRAMEWALKER is a medical device that received FDA 510(k) clearance on 2011-10-24. The listed applicant is Quantum Medical Concepts, LLC. The 510(k) number is K111993.

When did FRAMEWALKER receive FDA 510(k) clearance?

FRAMEWALKER received FDA 510(k) clearance on 2011-10-24, under 510(k) number K111993.

Who is the listed applicant for FRAMEWALKER?

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 FRAMEWALKER?

The FDA product code for FRAMEWALKER 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.

K101759QUANTUM RING FIXATION SYSTEM MODEL ISF

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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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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