MODIFICATION TO LAPIDUS PLATE
FDA 510(k) clearance K070241 · decided 2007-02-08
Clearance details
- K-number
- K070241
- Device name
- MODIFICATION TO LAPIDUS PLATE
- Applicant
- New Deal, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-25
- Decision date
- 2007-02-08
- Days to decision
- 14 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
+ Add to Predicate Builder ◉ Watch New Deal
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, N recall (Z-2123-2012) | Integra LifeSciences Corp. | 2012-08-01 |