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FDA 510(k), K183603, INnate Cannulated Screw System
FDA 510(k), K183603, INnate Cannulated Screw System
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510(K) Number: K183603
Device Name: INnate Cannulated Screw System
Manufacturer: Moira Barton-Varty
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: KXA
Date Received: 12/26/2018
Decision Date: 03/12/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: INnate Cannulated Screw System
Manufacturer: Moira Barton-Varty
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: KXA
Date Received: 12/26/2018
Decision Date: 03/12/2019
Decision: Substantially Equivalent (SESE)
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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