APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
FDA 510(k) clearance K051567 · decided 2005-08-23
Clearance details
- K-number
- K051567
- Device name
- APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
- Applicant
- Medartis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-14
- Decision date
- 2005-08-23
- Days to decision
- 70 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: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A recall (Z-1549-2026) | Medartis AG | 2026-03-10 |