Stativ® Knotted UHMWPE Suture Anchor— 510(k) K223889
Substantially EquivalentHealthium Medtech Limited
FDA 510(k) clearance K223889 for Stativ® Knotted UHMWPE Suture Anchor, Substantially Equivalent on 2023-03-22. Applicant: Healthium Medtech Limited. Device class: 2.
Clearance details
- Applicant
- Healthium Medtech Limited
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bangalore, IN
Recent devices under product code MBI
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view all- K231033 — CEPTRE® Knotted UHMWPE Suture PEEK Anchor
- K230891 — SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant
- K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.