NEWDEAL COMPRESSION PLATE
FDA 510(k) clearance K070447 · decided 2007-03-29
Clearance details
- K-number
- K070447
- Device name
- NEWDEAL COMPRESSION PLATE
- Applicant
- Newdeal Sas
- Decision
- Substantially Equivalent
- Date received
- 2007-02-15
- Decision date
- 2007-03-29
- Days to decision
- 42 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 |
|---|---|---|
| Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E8 recall (Z-0955-2011) | Integra LifeSciences Corp. | 2011-01-25 |
| Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newde recall (Z-0307-2009) | Integra LifeSciences Corp | 2008-12-01 |