FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
SpaceFlex Knee - 80mm Size
K Number: K201960
·
Decision Aug 13, 2020
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
18
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- SpaceFlex Knee - 80mm Size
- K Number
- K201960
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- G21, S.R.L.
- Date Received
- July 14, 2020
- Decision Date
- August 13, 2020
- Product Code
- MBB
- 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 |
|---|---|---|---|
| MBB | Bone Cement, Antibiotic | FDA class 2 | Orthopedic |
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Other Clearances by G21, S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | Sep 15, 2025 | Substantially Equivalent |
| K223441 | SpaceFlex Acetabular Cup | Mar 23, 2023 | Substantially Equivalent |
| K202338 | SpaceFlex Shoulder | Feb 17, 2021 | Substantially Equivalent |
| K193059 | G1 40 Radiopaque Bone Cement | Mar 19, 2020 | Substantially Equivalent |
| K193061 | G3 40 Radiopaque Bone Cement | Mar 19, 2020 | Substantially Equivalent |
| K192041 | G21 SpaceFlex Hip | Oct 29, 2019 | Substantially Equivalent |
| K190216 | SpaceFlex Knee | Jun 9, 2019 | Substantially Equivalent |
| K181282 | G3A 40 Bone Cement | Jan 9, 2019 | Substantially Equivalent |
| K173494 | OrthoSteady G Bone Cement | Mar 6, 2018 | Substantially Equivalent |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | Feb 23, 2016 | Substantially Equivalent |