FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Acumed Ankle Syndesmosis Repair System
K Number: K212990
·
Decision Jan 7, 2022
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
38
Review Days
109
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Basic Information
- Device Name
- Acumed Ankle Syndesmosis Repair System
- K Number
- K212990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acumed, LLC
- Date Received
- September 20, 2021
- Decision Date
- January 7, 2022
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Acumed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Aug 21, 2025 | Substantially Equivalent |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Jul 14, 2025 | Substantially Equivalent |
| K251296 | The Acumed Wrist Fixation System | Jun 18, 2025 | Substantially Equivalent |
| K243624 | Acu-Sinch Knotless Mini | Jan 23, 2025 | Substantially Equivalent |
| K233311 | Acumed Wrist Plating System | Apr 22, 2024 | Substantially Equivalent |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | Jun 9, 2023 | Substantially Equivalent |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Dec 29, 2022 | Substantially Equivalent |
| K210750 | Acumed Clavicle Hook Plating System | Jul 15, 2021 | Substantially Equivalent |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | Oct 30, 2015 | Substantially Equivalent |
| K143385 | Acumed Ankle Plating System | Apr 6, 2015 | Substantially Equivalent |