FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Remedy® Shoulder Spacer
K Number: K152267
·
Decision Dec 15, 2015
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
11
Review Days
126
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Basic Information
- Device Name
- Remedy® Shoulder Spacer
- K Number
- K152267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteoremedies, LLC
- Date Received
- August 11, 2015
- Decision Date
- December 15, 2015
- Product Code
- KWS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K231556 | SPECTRUM® GV Bone Cement | Dec 20, 2023 | Substantially Equivalent |
| K223650 | REMEDY Stemmed Knee Spacer | Jan 5, 2023 | Substantially Equivalent |
| K192995 | OsteoRemedies Hip Spacer System | Jan 10, 2020 | Substantially Equivalent |
| K191981 | REMEDY Acetabular Cup | Aug 23, 2019 | Substantially Equivalent |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Jul 25, 2019 | Substantially Equivalent |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Aug 29, 2018 | Substantially Equivalent |
| K173967 | Remedy Acetabular Cup | Feb 22, 2018 | Substantially Equivalent |