510(k) K262290

REMEDY POLY+PLUS SNAP FIT Acetabular Cup by Osteoremedies, LLC — Product Code KWL

K262290 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "REMEDY POLY+PLUS SNAP FIT Acetabular Cup". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2026
Date Received
July 6, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type