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FDA 510(k)

PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)

K-Number: K092017 · 2009-12-01

ApplicantCaptiva Spine, Inc.
Decision Date2009-12-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine, Inc.. It received FDA 510(k) clearance on 2009-12-01 under 510(k) number K092017. 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 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)?

PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) is a medical device that received FDA 510(k) clearance on 2009-12-01. The listed applicant is Captiva Spine, Inc.. The 510(k) number is K092017.

When did PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) receive FDA 510(k) clearance?

PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) received FDA 510(k) clearance on 2009-12-01, under 510(k) number K092017.

Who is the listed applicant for PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)?

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

What is the FDA product code for PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)?

The FDA product code for PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) is MAX.

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Other records listing Captiva Spine, 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.

K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemK181229TirboLOX-C Cervical IBFDK180990TirboLOX-L Lumbar IBFDK180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemK120292CAPLOX II PEDICLE SCREW SYSTEMK111115CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM

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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

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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