FDA 510(k), K213815, SiJoin®T3
FDA 510(k), K213815, SiJoin®T3
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510(K) Number: K213815
Device Name: SiJoin®T3
Manufacturer: VGI Medical, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 12/07/2021
Decision Date: 03/29/2023
Regulation Medical Specialty: Orthopedic
Device Name: SiJoin®T3
Manufacturer: VGI Medical, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 12/07/2021
Decision Date: 03/29/2023
Regulation Medical Specialty: Orthopedic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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