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FDA 510(k), K201572, TAPESTRY Biointegrative Implant
FDA 510(k), K201572, TAPESTRY Biointegrative Implant
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510(K) Number: K201572
Device Name: TAPESTRY Biointegrative Implant
Manufacturer: Embody, Inc.
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: 878.3300
Classification Product Code: OWY
Date Received: 06/11/2020
Decision Date: 10/19/2020
Regulation Medical Specialty: General & Plastic Surgery
Device Name: TAPESTRY Biointegrative Implant
Manufacturer: Embody, Inc.
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: 878.3300
Classification Product Code: OWY
Date Received: 06/11/2020
Decision Date: 10/19/2020
Regulation Medical Specialty: General & Plastic Surgery
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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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