TRIMED X-FIX
FDA 510(k) clearance K101375 · decided 2010-09-15
Clearance details
- K-number
- K101375
- Device name
- TRIMED X-FIX
- Applicant
- TriMed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-17
- Decision date
- 2010-09-15
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- NDK
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saugus, CA, 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 |
|---|---|---|
| VECTRIX EXTERNAL FIXATOR (K140649) | 3D Medical Concepts, LLC | 2014-12-29 |
| EXTERNAL FIXATOR SYSTEM (K122208) | Christopher D. Endara | 2012-12-20 |
Recalls involving this device
No recalls on record reference this clearance.