FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIMED X-FIX
K Number: K101375
·
Decision Sep 15, 2010
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
36
Review Days
121
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Basic Information
- Device Name
- TRIMED X-FIX
- K Number
- K101375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TriMed, Inc.
- Date Received
- May 17, 2010
- Decision Date
- September 15, 2010
- Product Code
- NDK
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDK | System, External Fixator (With Metallic Invasive Components) | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDK), ordered by most recent decision date.
VECTRIX EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
EXTERNAL FIXATOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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