FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAPESTRY Biointegrative Implant
K Number: K201572
·
Decision Oct 19, 2020
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
6
Review Days
130
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Basic Information
- Device Name
- TAPESTRY Biointegrative Implant
- K Number
- K201572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Embody, Inc.
- Date Received
- June 11, 2020
- Decision Date
- October 19, 2020
- Product Code
- OWY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Embody, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | Sep 19, 2025 | Substantially Equivalent |
| K223822 | ACTIVBRAID | Jun 2, 2023 | Substantially Equivalent |
| K220867 | Tapestry Biointegrative Implant | May 23, 2022 | Substantially Equivalent |
| K213958 | Bioabsorbable Anchor | Apr 8, 2022 | Substantially Equivalent |
| K212306 | Tapestry Biointegrative Implant | Nov 2, 2021 | Substantially Equivalent |