Data / Medical devices / United States / Tigon Medical LLC
Tigon Medical LLC: FDA-registered device maker in Millersville, MD, United States, 7 510(k) clearances
Tigon Medical LLC is registered with the FDA (registration 3015075784) in Millersville, MD, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015075784
- Address
- 303 Najoles Road Suite 104, Millersville, MD, United States, 21108
- Owner or operator
- Tigon Medical LLC (10059738)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 18, 2019
- Registered through
- 2026
- Brand names listed
- Boomerang Button, Knotless and Dual Javelin All-Suture Anchors, Lasso Suture Passer, Manticore, NDC (Non-Disposable Cannula), TIGO PRO 001 Knot Pusher, TIGO PRO 002 Shoulder Debridement Rasp, TIGO PRO 003 Shoulder Tissue Elevator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| December 4, 2025 | K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| December 20, 2024 | K242529 | Tigon Medical All-Suture Anchors (ASA) | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| October 29, 2024 | K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | HWC | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| March 22, 2023 | K220464 | Tigon Medical Gryphon Anchor Line | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| August 4, 2021 | K211049 | Tigon Medical Button System | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
| January 21, 2019 | K182507 | Tigon Medical Tissue Anchors | MBI | Substantially Equivalent | Tigon Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
Updated April 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.