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FDA 510(k)

BINDER INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K093015 · 2010-02-25

ApplicantBinder Biomedical, Inc.
Decision Date2010-02-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BINDER INTERVERTEBRAL BODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Binder Biomedical, Inc.. It received FDA 510(k) clearance on 2010-02-25 under 510(k) number K093015. 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 BINDER INTERVERTEBRAL BODY FUSION DEVICE?

BINDER INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-02-25. The listed applicant is Binder Biomedical, Inc.. The 510(k) number is K093015.

When did BINDER INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

BINDER INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2010-02-25, under 510(k) number K093015.

Who is the listed applicant for BINDER INTERVERTEBRAL BODY FUSION DEVICE?

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

What is the FDA product code for BINDER INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for BINDER INTERVERTEBRAL BODY FUSION DEVICE is MAX.

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 Binder Biomedical, 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.

K130641LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE

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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