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FDA 510(k), K213958, Bioabsorbable Anchor
FDA 510(k), K213958, Bioabsorbable Anchor
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510(K) Number: K213958
Device Name: Bioabsorbable Anchor
Manufacturer: Embody, Inc.
Device Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue
Regulation Number: 888.3030
Classification Product Code: MAI
Date Received: 12/17/2021
Decision Date: 04/08/2022
Regulation Medical Specialty: Orthopedic
Device Name: Bioabsorbable Anchor
Manufacturer: Embody, Inc.
Device Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue
Regulation Number: 888.3030
Classification Product Code: MAI
Date Received: 12/17/2021
Decision Date: 04/08/2022
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
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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