EXTERNAL FIXATOR SYSTEM
FDA 510(k) clearance K122208 · decided 2012-12-20
Clearance details
- K-number
- K122208
- Device name
- EXTERNAL FIXATOR SYSTEM
- Applicant
- Christopher D. Endara
- Decision
- Substantially Equivalent
- Date received
- 2012-07-25
- Decision date
- 2012-12-20
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- NDK
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami, FL, 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 |
| TRIMED X-FIX (K101375) | TriMed, Inc. | 2010-09-15 |
Recalls involving this device
No recalls on record reference this clearance.