SBI ULNAR HEAD IMPLANT
FDA 510(k) clearance K061146 · decided 2006-07-19
Clearance details
- K-number
- K061146
- Device name
- SBI ULNAR HEAD IMPLANT
- Applicant
- Small Bone Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-25
- Decision date
- 2006-07-19
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- KXE
- Device class
- 2
- Regulation number
- 888.3810
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aptis Medical Distal Radio Ulnar Joint Implant (K190599) | Aptis Medical, LLC | 2019-05-03 |
| Aptis Medical Distal Radio Ulnar Joint Implant (K142569) | Aptis Medical, LLC | 2015-04-03 |
| FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (K112481) | Ascension Orthopedic | 2012-04-09 |
| ISOELASTICU (K081025) | Remi Sciences, Inc. | 2008-11-21 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K082839) | Aptis Medical, LLC | 2008-10-24 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K053119) | Aptis Medical, LLC | 2005-12-07 |
| ASCENSION MUH (K052137) | Ascension Orthopedics, Inc. | 2005-11-03 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K040497) | Aptis Medical, LLC | 2005-01-26 |
| HERBERT ULNAR HEAD PROSTHESIS SYSTEM (K042902) | Stuckenbrock Medizintechnik GmbH | 2004-12-27 |
| KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (K033930) | Kapp Surgical Instrument, Inc. | 2004-07-28 |
| WMT MODULAR ULNAR HEAD IMPLANT (K020274) | Wrightmedicaltechnologyinc | 2002-02-22 |
| ULNAR HEAD IMPLANT (K010786) | Avanta Orthopaedics, Inc. | 2001-04-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of recall (Z-2427-2015) | Stryker Howmedica Osteonics Corp. | 2015-08-20 |
| Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replaceme recall (Z-2430-2015) | Stryker Howmedica Osteonics Corp. | 2015-08-20 |