THREADSTONE LLC

FDA Device Registration & Listing · Millersville, MD, US · Registration 3017499940

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017499940
FEI Number
3017499940
Entity Name
THREADSTONE LLC
City/State/Country
Millersville, MD, US
Establishment Address
1035 Benfield Blvd Ste H, Millersville, MD 21108, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Threadstone LLC (Owner Number: 10078443)
Owner / Operator Contact Address
1035 Benfield blvd, suite H, Millersville, MD 21108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HyperSuture HyperSuture Manticore anchor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-05-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-08-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-04-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-10-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-12-22

Official Correspondent

jeremy clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Threadstone LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017499940. Last updated year: 2026. Please use registration number 3017499940 when referencing this establishment in official correspondence.
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