FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoRemedies Hip Spacer System
K Number: K192995
·
Decision Jan 10, 2020
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
11
Review Days
77
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Basic Information
- Device Name
- OsteoRemedies Hip Spacer System
- K Number
- K192995
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteoremedies, LLC
- Date Received
- October 25, 2019
- Decision Date
- January 10, 2020
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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Other Clearances by Osteoremedies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253675 | OsteoRemedies Hip Spacer System | Dec 23, 2025 | Substantially Equivalent |
| K250760 | SPECTRUM GV Bone Cement | Apr 2, 2025 | Substantially Equivalent |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Oct 2, 2024 | Substantially Equivalent |
| K231556 | SPECTRUM® GV Bone Cement | Dec 20, 2023 | Substantially Equivalent |
| K223650 | REMEDY Stemmed Knee Spacer | Jan 5, 2023 | 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 |
| K152267 | Remedy® Shoulder Spacer | Dec 15, 2015 | Substantially Equivalent |