FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
K Number: K223342
·
Decision Mar 30, 2023
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
13
Review Days
149
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Basic Information
- Device Name
- MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
- K Number
- K223342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crossroads Extremity Systems, LLC
- Date Received
- November 1, 2022
- Decision Date
- March 30, 2023
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Crossroads Extremity Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K220797 | FootHold System | Apr 15, 2022 | Substantially Equivalent |
| K202268 | CrossRoads Tray System | Dec 30, 2020 | Substantially Equivalent |
| K190658 | MIS Bunion Plating System | Apr 12, 2019 | Substantially Equivalent |
| K181872 | MIS Bunion System | Feb 19, 2019 | Substantially Equivalent |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Aug 9, 2018 | Substantially Equivalent |
| K181410 | MotoCLIP/HiMAX Implant System | Jun 29, 2018 | Substantially Equivalent |
| K173710 | MotoBAND CP Implant System | Feb 12, 2018 | Substantially Equivalent |
| K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | May 3, 2016 | Substantially Equivalent |
| K160300 | MotoBand(TM) CP Implant System | Apr 22, 2016 | Substantially Equivalent |
| K152306 | MotoBand¿ CP Implant System | Dec 11, 2015 | Substantially Equivalent |