FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Regeneten Bioinductive Implant
K Number: K222501
·
Decision May 11, 2023
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
7
Review Days
266
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Basic Information
- Device Name
- Regeneten Bioinductive Implant
- K Number
- K222501
- 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
- Smith and Nephew, Inc.
- Date Received
- August 18, 2022
- Decision Date
- May 11, 2023
- 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
Other 510(k) clearances with the same product code (OWY), ordered by most recent decision date.
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REGENETEN Bioinductive Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tapestry Biointegrative Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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|---|---|---|---|
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| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | Aug 23, 2019 | Substantially Equivalent |
| K183232 | Double ENDOBUTTON Fixation Device | Mar 12, 2019 | Substantially Equivalent |
| K181746 | MICRORAPTOR Knotless Suture Anchor | Sep 28, 2018 | Substantially Equivalent |
| K180361 | MICRORAPTOR REGENESORB Suture Anchor | May 30, 2018 | Substantially Equivalent |
| K163034 | SUTUREFIX Curved Suture Anchor | Dec 7, 2016 | Substantially Equivalent |