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FDA 510(k)

TranS1 Interbody Fusion System

K-Number: K191791 · 2019-09-25

ApplicantTrans1
Decision Date2019-09-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TranS1 Interbody Fusion System is a medical device manufactured by Trans1. It received FDA 510(k) clearance on 2019-09-25 under approval number K191791. 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 TranS1 Interbody Fusion System?

TranS1 Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Trans1. The 510(k) number is K191791.

When was TranS1 Interbody Fusion System approved by the FDA?

TranS1 Interbody Fusion System received FDA 510(k) clearance on 2019-09-25, under approval number K191791.

What company makes TranS1 Interbody Fusion System?

TranS1 Interbody Fusion System is manufactured by Trans1.

What is the FDA product code for TranS1 Interbody Fusion System?

The FDA product code for TranS1 Interbody Fusion System 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 Trans1

K192792TranS1 AxiaLIF Plus 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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