FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioBrace®
K Number: K242187
·
Decision Nov 27, 2024
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
7
Applicant Total
14
Review Days
125
Basic Information
- Device Name
- BioBrace®
- K Number
- K242187
- 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
- CONMED Corporation
- Date Received
- July 25, 2024
- Decision Date
- November 27, 2024
- Product Code
- OWW
- 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 |
|---|---|---|---|
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CONMED Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251530 | CONMED Argo Knotless® Anchor | Jun 18, 2025 | Substantially Equivalent |
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| K240127 | PlumeSafe X5 Smoke Management System | Aug 5, 2024 | Substantially Equivalent |
| K241906 | BioBrace® Reinforced Implant | Jul 29, 2024 | Substantially Equivalent |
| K240090 | Argo Knotless GENESYS Anchor | Mar 5, 2024 | Substantially Equivalent |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Sep 20, 2023 | Substantially Equivalent |
| K220186 | Zone Specific AIM | May 13, 2022 | Substantially Equivalent |
| K220757 | Argo Knotless SP Anchor | May 13, 2022 | Substantially Equivalent |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | Jun 1, 2020 | Substantially Equivalent |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Jun 28, 2019 | Substantially Equivalent |