MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
FDA 510(k) clearance K223342 · decided 2023-03-30
Clearance details
- K-number
- K223342
- Device name
- MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
- Applicant
- Crossroads Extremity Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-11-01
- Decision date
- 2023-03-30
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.