NEWDEAL COMPRESSION PLATE
FDA 510(k) clearance K091609 · decided 2009-06-30
Clearance details
- K-number
- K091609
- Device name
- NEWDEAL COMPRESSION PLATE
- Applicant
- Newdeal Sas
- Decision
- Substantially Equivalent
- Date received
- 2009-06-03
- Decision date
- 2009-06-30
- Days to decision
- 27 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E8 recall (Z-0955-2011) | Integra LifeSciences Corp. | 2011-01-25 |