FDA 510(k)

S-LIF INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K092815 · 2010-06-30

Decision Date2010-06-30

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

S-LIF INTERVERTEBRAL BODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K092815. 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 S-LIF INTERVERTEBRAL BODY FUSION DEVICE?

S-LIF INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K092815.

When did S-LIF INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

S-LIF INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2010-06-30, under 510(k) number K092815.

Who is the listed applicant for S-LIF INTERVERTEBRAL BODY FUSION DEVICE?

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

What is the FDA product code for S-LIF INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for S-LIF INTERVERTEBRAL BODY FUSION DEVICE is MAX.

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Other records listing Spinefrontier, Inc. as applicant

K193106SpineFrontier Lumbar Interbody Fusion Device System K172484A-CIFT SoloFuse K132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM K123164SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM K121060SPINE FRONTIER INDUS ACP SYSTEM K113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift 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 Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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.