FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bioabsorbable Anchor
K Number: K213958
·
Decision Apr 8, 2022
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
6
Review Days
112
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Basic Information
- Device Name
- Bioabsorbable Anchor
- K Number
- K213958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Embody, Inc.
- Date Received
- December 17, 2021
- Decision Date
- April 8, 2022
- Product Code
- MAI
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Embody, Inc.
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|---|---|---|---|
| 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 |
| K212306 | Tapestry Biointegrative Implant | Nov 2, 2021 | Substantially Equivalent |
| K201572 | TAPESTRY Biointegrative Implant | Oct 19, 2020 | Substantially Equivalent |