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FDA 510(k)

INFILL OBLIQUE TLIF DEVICE

K-Number: K124012 · 2013-06-04

ApplicantPinnacle Spine Group, LLC
Decision Date2013-06-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFILL OBLIQUE TLIF DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pinnacle Spine Group, LLC. It received FDA 510(k) clearance on 2013-06-04 under 510(k) number K124012. 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 INFILL OBLIQUE TLIF DEVICE?

INFILL OBLIQUE TLIF DEVICE is a medical device that received FDA 510(k) clearance on 2013-06-04. The listed applicant is Pinnacle Spine Group, LLC. The 510(k) number is K124012.

When did INFILL OBLIQUE TLIF DEVICE receive FDA 510(k) clearance?

INFILL OBLIQUE TLIF DEVICE received FDA 510(k) clearance on 2013-06-04, under 510(k) number K124012.

Who is the listed applicant for INFILL OBLIQUE TLIF DEVICE?

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

What is the FDA product code for INFILL OBLIQUE TLIF DEVICE?

The FDA product code for INFILL OBLIQUE TLIF DEVICE is MAX.

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Other records listing Pinnacle Spine Group, LLC 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.

K172349InFill® Interbody Fusion DeviceK121476INFILL GRAFT DELIVERY SYSTEMK121733INFILL INTERVERTEBRAL BODY FUSION DEVICEK111632INFILL GRAFT DELIVERY SYSTEMK103729INFILL 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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