FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
K Number: K242865
·
Decision Jun 12, 2025
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
27
Review Days
265
Basic Information
- Device Name
- Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
- K Number
- K242865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocomposites, Ltd.
- Date Received
- September 20, 2024
- Decision Date
- June 12, 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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