FASTX STERNAL INTRAOSSEOUS DEVICE
FDA 510(k) clearance K100124 · decided 2010-08-31
Clearance details
- K-number
- K100124
- Device name
- FASTX STERNAL INTRAOSSEOUS DEVICE
- Applicant
- Pyng Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-19
- Decision date
- 2010-08-31
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Richmond, Bc, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recall recall (Z-2687-2011) | Pyng Medical Corporation | 2011-06-28 |