FDA.report

510(k) K252666

Device
Articulator Arthroscopic Bur
Applicant
Joint Preservation Innovations, LLC
510(k) number
K252666
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-21
Date received
2025-08-25
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sanjeev Bhatia
Address
115 E. Ogden Ave. Suite 105-323 Naperville IL US 60563 60563

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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