REMEDY POLY+PLUS SNAP FIT Acetabular Cup— 510(k) K262290
Substantially EquivalentOsteoremedies, LLC
FDA 510(k) clearance K262290 for REMEDY POLY+PLUS SNAP FIT Acetabular Cup, Substantially Equivalent on 2026-07-24. Applicant: Osteoremedies, LLC. Device class: 2.
Summary
Osteoremedies' REMEDY POLY+PLUS SNAP FIT Acetabular Cup is filed under KWL, metal femoral hemi-hip prostheses. The device name describes an acetabular cup, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 888.3360. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
Osteoremedies filed from Germantown, Tennessee. Review took 18 calendar days (July 6 to July 24, 2026).
Clearance details
- Applicant
- Osteoremedies, LLC
- Product code
- Product code KWL
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Germantown, TN, US
Recent devices under product code KWL
view allMore clearances from Osteoremedies, LLC
view allAdverse events under product code KWL
product code KWL- Injury
- 523
- Total
- 523
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.