CROSSROADS EXTREMITY SYSTEMS LLC

FDA Device Registration & Listing · Memphis, TN, US · Registration 3020584246

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
3020584246
FEI Number
3020584246
Entity Name
CROSSROADS EXTREMITY SYSTEMS LLC
City/State/Country
Memphis, TN, US
Establishment Address
6423 Shelby View Dr, Suite 101, Memphis, TN 38134, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CrossRoads Extremity Systems LLC (Owner Number: 10048591)
Owner / Operator Contact Address
6423 Shelby View Dr, Suite 101, Memphis, TN 38134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MotoBAND MotoBAND Max VERO SPEEDBUTTON ANCHOR SYSTEM FootHold System CrossRoads Tray System MotoBand CP DynaForce TriLEAP Plating System DynaForce TriLEAP Plating System TriLEAP Plating System CrossTIE Instraosseous Fixation System STROPP TriLEAP Plating System MotoBAND CP DynaFORCE MotoBAND Max DynaFORCE VERO DynaFORCE STROPP TriLEAP Plating System Pin Allograft Template MotoBAND CP Implant System MotoBand CP TriLEAP Plating System MotoBand CP CrossTIE DynaForce CrossRoads Screw System MotoCLIP CrossRoads Screw System CrossTIE CrossRoads Modular Tray System STROPP MotoBAND Max MotoBAND CP DynaForce CrossRoads Screw System MotoBand CP Broach CrossRoads Screw System MotoBand CP TriLEAP Plating System TriLEAP Plating System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-12-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-08-21
HWT Template Orthopedic Class 1 888.4800 2018-05-03
HWB Extractor Orthopedic Class 1 888.4540 2023-11-08
HXG Tamp Orthopedic Class 1 888.4540 2018-05-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-29
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-05-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-04-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-04-25
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2018-05-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2019-12-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-11-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-11-08
HXW Bender Orthopedic Class 1 888.4540 2018-05-03
HXX Screwdriver Orthopedic Class 1 888.4540 2018-05-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-07-17
HWQ Passer Orthopedic Class 1 888.4540 2018-05-03
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2019-05-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-26
HWW Countersink Orthopedic Class 1 888.4540 2018-05-03
HXB Probe Orthopedic Class 1 888.4540 2018-05-03
HTQ Broach Orthopedic Class 1 888.4540 2024-02-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-05-10
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2018-05-03
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2023-11-08
HWX Tap, Bone Orthopedic Class 1 888.4540 2026-01-07

Official Correspondent

Angela Marik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CrossRoads Extremity Systems 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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020584246. Last updated year: 2026. Please use registration number 3020584246 when referencing this establishment in official correspondence.
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