DORSAL NAIL PLATE, ANATOMICAL
FDA 510(k) clearance K052248 · decided 2005-09-14
Clearance details
- K-number
- K052248
- Device name
- DORSAL NAIL PLATE, ANATOMICAL
- Applicant
- Hand Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-08-18
- Decision date
- 2005-09-14
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, recall (Z-2212-2014) | Biomet, Inc. | 2014-08-13 |
| DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; recall (Z-0981-2009) | Depuy Orthopaedics, Inc. | 2009-02-11 |
| DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJI recall (Z-0982-2009) | Depuy Orthopaedics, Inc. | 2009-02-11 |
| DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL recall (Z-0983-2009) | Depuy Orthopaedics, Inc. | 2009-02-11 |
| DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPA recall (Z-0984-2009) | Depuy Orthopaedics, Inc. | 2009-02-11 |