TRIHA +
FDA 510(k) clearance K031826 · decided 2003-11-28
Clearance details
- K-number
- K031826
- Device name
- TRIHA +
- Applicant
- Teknimed, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-13
- Decision date
- 2003-11-28
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers recall (Z-0423-2007) | Teknimed SA | 2007-02-22 |