Panels › Orthopedic › Product code NDK · Class 2
System, External Fixator (With Metallic Invasive Components)
Regulation 888.3040
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NDK
| Company | 510(k)s | Recalls |
|---|---|---|
| 3D Medical Concepts, LLC | 1 | 0 |
| Christopher D. Endara | 1 | 0 |
| TriMed, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 2014 | K140649 | VECTRIX EXTERNAL FIXATOR 3D Medical Concepts, LLC | NDK |
| Dec 20, 2012 | K122208 | EXTERNAL FIXATOR SYSTEM Christopher D. Endara | NDK |
| Sep 15, 2010 | K101375 | TRIMED X-FIX TriMed, Inc. | NDK |
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