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FDA 510(k), K180818, Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA 510(k), K180818, Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
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510(K) Number: K180818
Device Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Manufacturer: Tenon Medical, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 03/29/2018
Decision Date: 06/13/2018
Regulation Medical Specialty: Orthopedic
Device Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Manufacturer: Tenon Medical, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 03/29/2018
Decision Date: 06/13/2018
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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