RESPONSIVE ARTHROSCOPY

FDA Device Registration & Listing · Minneapolis, MN, US · Registration 3015200759

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
3015200759
FEI Number
3015200759
Entity Name
RESPONSIVE ARTHROSCOPY
City/State/Country
Minneapolis, MN, US
Establishment Address
701 N 3rd Street, Suite 208, Minneapolis, MN 55401, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Responsive Arthroscopy (Owner Number: 10059367)
Owner / Operator Contact Address
701 N 3rd Street, Suite 208, Minneapolis, MN 55401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Superhawk Instruments-Spirit, Hornet, Lightning, Nighthawk, Superhawk, Mini Superhawk, Thunderbolt, Mini Stealth, Stealth, Shadow Stealth and Mini Stealth All-Suture Anchors, Shadow and Shadow Mini All-Suture Anchors Shadow Knotless All-Suture Anchors Nighthawk Suture Anchor Osprey Suture Anchor Falcon Spirit Mustang and Mustang Knotless Vented Suture Anchors Eagle and Eagle Knotless Suture Anchors Spirit Agile Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-03-30
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-03-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-08-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-03-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-12-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-10-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-12-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-10-17
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-12-27

Official Correspondent

Gretchen Hinchley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Responsive Arthroscopy
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
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
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015200759. Last updated year: 2026. Please use registration number 3015200759 when referencing this establishment in official correspondence.
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