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FDA 510(k), K180744, Stablyx CMC Arthroplasty Implant System
FDA 510(k), K180744, Stablyx CMC Arthroplasty Implant System
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510(K) Number: K180744
Device Name: Stablyx CMC Arthroplasty Implant System
Manufacturer: Skeletal Dynamics, LLC
Device Classification Name: prosthesis, wrist, carpal trapezium
Regulation Number: 888.3770
Classification Product Code: KYI
Date Received: 03/22/2018
Decision Date: 04/11/2018
Regulation Medical Specialty: Orthopedic
Device Name: Stablyx CMC Arthroplasty Implant System
Manufacturer: Skeletal Dynamics, LLC
Device Classification Name: prosthesis, wrist, carpal trapezium
Regulation Number: 888.3770
Classification Product Code: KYI
Date Received: 03/22/2018
Decision Date: 04/11/2018
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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