APTUS FOOT SYSTEM
FDA 510(k) clearance K091479 · decided 2009-07-13
Clearance details
- K-number
- K091479
- Device name
- APTUS FOOT SYSTEM
- Applicant
- Medartis AG
- Decision
- Substantially Equivalent
- Date received
- 2009-05-19
- Decision date
- 2009-07-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A recall (Z-1550-2026) | Medartis AG | 2026-03-10 |
| APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS recall (Z-1821-2024) | Medartis Inc. | 2024-05-14 |