NEWDEAL ANKLE NAIL
FDA 510(k) clearance K050882 · decided 2005-05-27
Clearance details
- K-number
- K050882
- Device name
- NEWDEAL ANKLE NAIL
- Applicant
- New Deal, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-07
- Decision date
- 2005-05-27
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- 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 PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis recall (Z-1736-2013) | Integra LifeSciences Corporation | 2013-07-16 |
| Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted recall (Z-1428-2012) | Integra LifeSciences Corp. | 2012-04-16 |
| Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The recall (Z-0308-2011) | Integra LifeSciences Corporation | 2010-11-02 |
| PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plain recall (Z-1877-2008) | Integra LifeSciences Corp. | 2008-09-16 |