EXCELLA III-D SPINAL DEFORMITY SYSTEM
FDA 510(k) clearance K140238 · decided 2014-05-07
Clearance details
- K-number
- K140238
- Device name
- EXCELLA III-D SPINAL DEFORMITY SYSTEM
- Applicant
- Innovasis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-30
- Decision date
- 2014-05-07
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55 recall (Z-0662-2016) | Innovasis, Inc | 2016-01-19 |
| Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For recall (Z-2067-2014) | Innovasis, Inc | 2014-07-16 |