VECTRIX EXTERNAL FIXATOR
FDA 510(k) clearance K140649 · decided 2014-12-29
Clearance details
- K-number
- K140649
- Device name
- VECTRIX EXTERNAL FIXATOR
- Applicant
- 3D Medical Concepts, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-03-13
- Decision date
- 2014-12-29
- Days to decision
- 291 days
- Clearance type
- Abbreviated
- Product code
- NDK
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pelham, AL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EXTERNAL FIXATOR SYSTEM (K122208) | Christopher D. Endara | 2012-12-20 |
| TRIMED X-FIX (K101375) | TriMed, Inc. | 2010-09-15 |
Recalls involving this device
No recalls on record reference this clearance.