Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line— 510(k) K260921
Substantially EquivalentTigon Medical
FDA 510(k) clearance K260921 for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line, Substantially Equivalent on 2026-04-21. Applicant: Tigon Medical. Device class: 2.
Summary
Tigon Medical's record covers the Static Javelin All-Suture Anchors and the Javelin All-Suture Anchor Line under one name, filed under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
Tigon Medical filed from Millersville, Maryland. The record shows 33 calendar days from receipt to decision (March 19 to April 21, 2026).
Clearance details
- Applicant
- Tigon Medical
- Product code
- Product 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
- Millersville, MD, US
Recent devices under product code MBI
view allMore clearances from Tigon Medical
view allAdverse 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.