FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TiLink-P SI Joint Fusion System
K Number: K243835
·
Decision Dec 27, 2024
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
25
Review Days
14
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Basic Information
- Device Name
- TiLink-P SI Joint Fusion System
- K Number
- K243835
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SurGenTec, LLC
- Date Received
- December 13, 2024
- Decision Date
- December 27, 2024
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUR), ordered by most recent decision date.
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OptumSI Implant System
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SIros-X System
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