Cleared Traditional

VantageTM Lumbar Decompression Kit

K252546 · Allevion Medical, LLC · Orthopedic

Mar 2026

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K252546 is an FDA 510(k) clearance for the VantageTM Lumbar Decompression Kit, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Allevion Medical, LLC (Boca Raton, US). The FDA issued a Cleared decision on March 12, 2026, 212 days after receiving the submission on August 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K252546 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2025
Decision Date	March 12, 2026
Days to Decision	212 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).