Betta Link Knotless Implant System— 510(k) K210498
Substantially EquivalentT.A.G. Medical Products Corporation, Ltd.
FDA 510(k) clearance K210498 for Betta Link Knotless Implant System, Substantially Equivalent on 2021-03-24. Applicant: T.A.G. Medical Products Corporation, Ltd.. Device class: 2.
Clearance details
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
- 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
- Special
- Location
- Gaaton, IL
Recent devices under product code MBI
view allMore clearances from T.A.G. Medical Products Corporation, Ltd.
view all- K253858 — GFS - Sterile Screws and Top Hat
- K231400 — Bladeless Trocar Artemis Lap Cannula
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- K202178 — VersaLoop Anchor System
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 →
Recalls naming K210498
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210498.
Data sourced from openFDA. This site is unofficial and independent of the FDA.