PRADO Lumbar Interbody Fusion System
K-Number: K252113 · 2025-08-05
ApplicantBethesda Medical Devices
Decision Date2025-08-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PRADO Lumbar Interbody Fusion System is a medical device manufactured by Bethesda Medical Devices. It received FDA 510(k) clearance on 2025-08-05 under approval number K252113. 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 PRADO Lumbar Interbody Fusion System?
PRADO Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-08-05. It is manufactured by Bethesda Medical Devices. The 510(k) number is K252113.
When was PRADO Lumbar Interbody Fusion System approved by the FDA?
PRADO Lumbar Interbody Fusion System received FDA 510(k) clearance on 2025-08-05, under approval number K252113.
What company makes PRADO Lumbar Interbody Fusion System?
PRADO Lumbar Interbody Fusion System is manufactured by Bethesda Medical Devices.
What is the FDA product code for PRADO Lumbar Interbody Fusion System?
The FDA product code for PRADO Lumbar 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
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
NCT04823858
3Spine Lumbar Fusion Real World Evidence Study
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NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
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)
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K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
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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.