Tigon Medical All-Suture Anchors (ASA)— 510(k) K242529
Substantially EquivalentTigon Medical
FDA 510(k) clearance K242529 for Tigon Medical All-Suture Anchors (ASA), Substantially Equivalent on 2024-12-20. Applicant: Tigon Medical. Device class: 2.
Clearance details
- Applicant
- Tigon Medical
- 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
- Millersville, MD, US
Recent devices under product code MBI
view allMore clearances from Tigon Medical
view all- K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
- K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors
- K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- K220464 — Tigon Medical Gryphon Anchor Line
- K211049 — Tigon Medical Button 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.