ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
FDA 510(k) clearance K113318 · decided 2012-01-12
Clearance details
- K-number
- K113318
- Device name
- ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
- Applicant
- Acute Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-11-10
- Decision date
- 2012-01-12
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- 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 |
|---|---|---|
| The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates a recall (Z-0852-2014) | ACUTE Innovations, LLC | 2014-01-28 |