NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
FDA 510(k) clearance K022324 · decided 2002-09-17
Clearance details
- K-number
- K022324
- Device name
- NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
- Applicant
- Osteomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-17
- Decision date
- 2002-09-17
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paramus, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #5 recall (Z-1524-2009) | Ascension Orthopedics, Inc | 2009-06-26 |