SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant— 510(k) K230891
Substantially EquivalentHealthium Medtech Limited
FDA 510(k) clearance K230891 for SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant, Substantially Equivalent on 2023-12-28. 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
view allMore clearances from Healthium Medtech Limited
view all- K231033 — CEPTRE® Knotted UHMWPE Suture PEEK Anchor
- 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
- K223889 — Stativ® Knotted UHMWPE Suture Anchor
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.