Data / Medical devices / United States / Threadstone LLC
Threadstone LLC: FDA-registered device maker in Millersville, MD, United States, 5 510(k) clearances
Threadstone LLC is registered with the FDA (registration 3017499940) in Millersville, MD, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 23, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017499940
- Address
- 1035 Benfield Blvd Ste H, Millersville, MD, United States, 21108
- Owner or operator
- Threadstone LLC (10078443)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- October 22, 2020
- Registered through
- 2027
- Brand names listed
- HyperSuture, Manticore anchor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Contract manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 23, 2026 | K254275 | HyperSuture All Green Extension Line | GAT | Substantially Equivalent | Threadstone, LLC | accessdata.fda.gov |
| March 27, 2025 | K242201 | HyperSuture White/Green Extension Line | GAT | Substantially Equivalent | Threadstone, LLC | accessdata.fda.gov |
| August 9, 2024 | K241376 | HyperSuture All Blue Extension Line | GAT | Substantially Equivalent | Threadstone, LLC | accessdata.fda.gov |
| May 10, 2024 | K234079 | HyperSuture Extension Line | GAT | Substantially Equivalent | Threadstone, LLC | accessdata.fda.gov |
| November 24, 2023 | K230311 | HyperSuture | GAT | Substantially Equivalent | Threadstone, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated March 23, 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.