510(k) K212306
K212306 is an FDA 510(k) premarket notification submitted by Embody, Inc. for the device "Tapestry Biointegrative Implant". The FDA issued a decision of Substantially Equivalent on November 2, 2021. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Embody, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2021
- Date Received
- July 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in tendon repair.