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FDA 510(k)

BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM

K-Number: K111512 · 2011-10-26

ApplicantThompson Mis, Inc.
Decision Date2011-10-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Mis, Inc.. It received FDA 510(k) clearance on 2011-10-26 under 510(k) number K111512. 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 BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM?

BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-26. The listed applicant is Thompson Mis, Inc.. The 510(k) number is K111512.

When did BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM receive FDA 510(k) clearance?

BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM received FDA 510(k) clearance on 2011-10-26, under 510(k) number K111512.

Who is the listed applicant for BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM?

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

What is the FDA product code for BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM?

The FDA product code for BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM is MAX.

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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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