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FDA 510(k)

ostaPek Interbody Fusion Cages

K-Number: K181963 · 2018-11-14

ApplicantColigne AG
Decision Date2018-11-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ostaPek Interbody Fusion Cages is the device name listed in this FDA 510(k) record. The listed applicant is Coligne AG. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181963. 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 ostaPek Interbody Fusion Cages?

ostaPek Interbody Fusion Cages is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Coligne AG. The 510(k) number is K181963.

When did ostaPek Interbody Fusion Cages receive FDA 510(k) clearance?

ostaPek Interbody Fusion Cages received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181963.

Who is the listed applicant for ostaPek Interbody Fusion Cages?

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

What is the FDA product code for ostaPek Interbody Fusion Cages?

The FDA product code for ostaPek Interbody Fusion Cages is MAX.

Related Clinical Trials

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.

NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITINGNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING

Other records listing Coligne AG 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.

K210306GII Spinal Fixation SystemK173893TrabisK173148ACIF

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.

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 CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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