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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 a medical device manufactured by Coligne AG. It received FDA 510(k) clearance on 2018-11-14 under approval 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. It is manufactured by Coligne AG. The 510(k) number is K181963.

When was ostaPek Interbody Fusion Cages approved by the FDA?

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

What company makes ostaPek Interbody Fusion Cages?

ostaPek Interbody Fusion Cages is manufactured by Coligne AG.

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Coligne AG

K173148ACIF K173893Trabis K210306GII Spinal Fixation System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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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