ACUMED SMALL BONE LOCKING ROD SYSTEM II
FDA 510(k) clearance K031438 · decided 2003-07-17
Clearance details
- K-number
- K031438
- Device name
- ACUMED SMALL BONE LOCKING ROD SYSTEM II
- Applicant
- Acumed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-05-06
- Decision date
- 2003-07-17
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hillsboro, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or recall (Z-1552-2010) | Acumed LLC | 2010-05-10 |