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FDA 510(k)

MEDICAL CONCEPTS INTERBODY FUSION SYSTEM

K-Number: K110659 · 2011-09-13

ApplicantMedical Concepts, Inc.
Decision Date2011-09-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDICAL CONCEPTS INTERBODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Concepts, Inc.. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K110659. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL CONCEPTS INTERBODY FUSION SYSTEM?

MEDICAL CONCEPTS INTERBODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Medical Concepts, Inc.. The 510(k) number is K110659.

When did MEDICAL CONCEPTS INTERBODY FUSION SYSTEM receive FDA 510(k) clearance?

MEDICAL CONCEPTS INTERBODY FUSION SYSTEM received FDA 510(k) clearance on 2011-09-13, under 510(k) number K110659.

Who is the listed applicant for MEDICAL CONCEPTS INTERBODY FUSION SYSTEM?

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

What is the FDA product code for MEDICAL CONCEPTS INTERBODY FUSION SYSTEM?

The FDA product code for MEDICAL CONCEPTS INTERBODY FUSION SYSTEM is MAX.

Related Clinical Trials

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Other records listing Medical Concepts, Inc. 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.

K940283KARL STORZ ENDOVISION UROCAM/HYSTEROCAMK883944MEC-1 VIDEO COMBO SYSTEMK883943CCM-1 VIDEO CAMERA SYSTEMK802564MEDICAL MAGNETIC TAPE RECORDER

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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