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FDA 510(k)

X-Pac Expandable Lumbar Cage System

K-Number: K203802 · 2021-06-07

ApplicantExpanding Innovations, Inc.
Decision Date2021-06-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-Pac Expandable Lumbar Cage System is a medical device manufactured by Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2021-06-07 under approval number K203802. 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 X-Pac Expandable Lumbar Cage System?

X-Pac Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2021-06-07. It is manufactured by Expanding Innovations, Inc.. The 510(k) number is K203802.

When was X-Pac Expandable Lumbar Cage System approved by the FDA?

X-Pac Expandable Lumbar Cage System received FDA 510(k) clearance on 2021-06-07, under approval number K203802.

What company makes X-Pac Expandable Lumbar Cage System?

X-Pac Expandable Lumbar Cage System is manufactured by Expanding Innovations, Inc..

What is the FDA product code for X-Pac Expandable Lumbar Cage System?

The FDA product code for X-Pac Expandable Lumbar Cage System is MAX.

Related Clinical Trials

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 NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

Other Devices by Expanding Innovations, Inc.

K201145X-Pac Expandable Lumbar Cage System K222797X-Pac Expandable Lumbar Cage System K220655X-Pac Expandable Lumbar Cage System K223174X-Pac Expandable LLIF Cage System K251003X-PAC® LLIF Expandable Lateral Cage System K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System

View all 8 devices →

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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