SBI LATERAL RADIO CAPITELLUM
FDA 510(k) clearance K070236 · decided 2007-02-21
Clearance details
- K-number
- K070236
- Device name
- SBI LATERAL RADIO CAPITELLUM
- Applicant
- Small Bone Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-25
- Decision date
- 2007-02-21
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- JDB
- Device class
- 2
- Regulation number
- 888.3160
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Newyork, NY, US
- Third-party review
- No
- Expedited review
- No
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| RHEAD RADIAL HEAD EXTENDED STEMS (K102180) | Small Bone Innovations, Inc. | 2010-12-20 |
| LATITUDE ELBOW PROSTHESIS (K100562) | Tornier, Inc. | 2010-06-29 |
| LATITUDE ELBOW PROTHESIS (K070787) | Tornier | 2007-08-24 |
| RHS (K060438) | Tornier | 2006-04-18 |
| SBI RADIO-CAPITELLAR IMPLANT (K060038) | Small Bone Innovations, Inc. | 2006-03-30 |
| TORNIER ELBOW PROSTHESIS (K050848) | Tornier | 2005-07-14 |
| MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) | Tornier | 2003-05-16 |
| TORNIER TOTAL ELBOW PROSTHESIS (K011567) | Tornier | 2001-06-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the recall (Z-2428-2015) | Stryker Howmedica Osteonics Corp. | 2015-08-20 |
| Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial St recall (Z-0098-2014) | Small Bone Innovations, Inc. | 2013-10-29 |