FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
InterSpace GV Hip Spacer
K Number: K252326
·
Decision Aug 6, 2025
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
14
Review Days
12
Basic Information
- Device Name
- InterSpace GV Hip Spacer
- K Number
- K252326
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tecres S.P.A.
- Date Received
- July 25, 2025
- Decision Date
- August 6, 2025
- 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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