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FDA 510(k)

ACCULIF TL-PEEK CAGE

K-Number: K123281 · 2013-01-23

ApplicantCoalign Innovations, Inc.
Decision Date2013-01-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCULIF TL-PEEK CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Coalign Innovations, Inc.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K123281. 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 ACCULIF TL-PEEK CAGE?

ACCULIF TL-PEEK CAGE is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Coalign Innovations, Inc.. The 510(k) number is K123281.

When did ACCULIF TL-PEEK CAGE receive FDA 510(k) clearance?

ACCULIF TL-PEEK CAGE received FDA 510(k) clearance on 2013-01-23, under 510(k) number K123281.

Who is the listed applicant for ACCULIF TL-PEEK CAGE?

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

What is the FDA product code for ACCULIF TL-PEEK CAGE?

The FDA product code for ACCULIF TL-PEEK CAGE is MAX.

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Other records listing Coalign Innovations, 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.

K132505ACCULIF TL AND PL CAGEK131443COALIGN INNOVATIONS ACCULIF XL IBF CAGEK130194ACCULIF XL CAGEK123752ACCULIF TL AND PL CAGEK121683ACCULIF TL CAGEK113465ACCULIF TL CAGE

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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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