FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRUM® GV Bone Cement
K Number: K231556
·
Decision Dec 20, 2023
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
11
Review Days
204
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Basic Information
- Device Name
- SPECTRUM® GV Bone Cement
- K Number
- K231556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteoremedies, LLC
- Date Received
- May 30, 2023
- Decision Date
- December 20, 2023
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| 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 |
| K152267 | Remedy® Shoulder Spacer | Dec 15, 2015 | Substantially Equivalent |