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FDA 510(k)

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

K-Number: K162212 · 2017-05-19

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2017-05-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K162212. 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 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM?

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162212.

When was DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM approved by the FDA?

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM received FDA 510(k) clearance on 2017-05-19, under approval number K162212.

What company makes DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM?

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM?

The FDA product code for DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM is MAX.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

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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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