NEWDEAL TIBIAXYS SYSTEM
FDA 510(k) clearance K073375 · decided 2008-02-21
Clearance details
- K-number
- K073375
- Device name
- NEWDEAL TIBIAXYS SYSTEM
- Applicant
- Newdeal Sas
- Decision
- Substantially Equivalent
- Date received
- 2007-12-03
- Decision date
- 2008-02-21
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and recall (Z-1697-2014) | Integra LifeSciences Corporation | 2014-06-02 |