FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
SpaceFlex Acetabular Cup
K Number: K223441
·
Decision Mar 23, 2023
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
12
Review Days
129
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Basic Information
- Device Name
- SpaceFlex Acetabular Cup
- K Number
- K223441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- G21, S.R.L.
- Date Received
- November 14, 2022
- Decision Date
- March 23, 2023
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 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 |
| K202338 | SpaceFlex Shoulder | Feb 17, 2021 | Substantially Equivalent |
| K201960 | SpaceFlex Knee - 80mm Size | Aug 13, 2020 | 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 |