510(k) K191981
K191981 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "REMEDY Acetabular Cup". The FDA issued a decision of Substantially Equivalent on August 23, 2019. 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
- August 23, 2019
- Date Received
- July 24, 2019
- 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