NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
FDA 510(k) clearance K014263 · decided 2002-03-08
Clearance details
- K-number
- K014263
- Device name
- NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2001-12-27
- Decision date
- 2002-03-08
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, recall (Z-0610-2009) | Stryker Leibinger USA | 2008-12-30 |