FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K Number: K232886
·
Decision Nov 8, 2023
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
5
Review Days
51
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Basic Information
- Device Name
- INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- K Number
- K232886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healthium Medtech Limited
- Date Received
- September 18, 2023
- Decision Date
- November 8, 2023
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Healthium Medtech Limited
| K Number | Device Name | ||
|---|---|---|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Jan 4, 2024 | Substantially Equivalent |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Dec 28, 2023 | Substantially Equivalent |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Aug 4, 2023 | Substantially Equivalent |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Mar 22, 2023 | Substantially Equivalent |