TxTi IBF System
FDA 510(k) clearance K183064 · decided 2019-06-28
Clearance details
- K-number
- K183064
- Device name
- TxTi IBF System
- Applicant
- Innovasis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-05
- Decision date
- 2019-06-28
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- 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 |
|---|---|---|
| TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is recall (Z-3163-2024) | Innovasis, Inc | 2024-09-17 |