FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Stativ® Knotted UHMWPE Suture Anchor
K Number: K223889
·
Decision Mar 22, 2023
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
5
Review Days
85
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Basic Information
- Device Name
- Stativ® Knotted UHMWPE Suture Anchor
- K Number
- K223889
- 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
- December 27, 2022
- Decision Date
- March 22, 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 |
Similar 510(k) Clearances
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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 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Nov 8, 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 |