FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAUMA-FIX EXTERNAL FIXATOR
K Number: K971272
·
Decision Jun 5, 1997
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
4
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRAUMA-FIX EXTERNAL FIXATOR
- K Number
- K971272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trend Medical, Inc.
- Date Received
- April 4, 1997
- Decision Date
- June 5, 1997
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTW), ordered by most recent decision date.
PK High Tibial Osteotomy Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
AOS Anterolateral Proximal Humeral Plate
FDA 510(k)
FDA Class 2
·Orthopedic
Phantom Small Bone Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
AOS Anterolateral Proximal Humeral Plate
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
FDA 510(k)
FDA Class 2
·Orthopedic
AOS PROXIMAL HUMERAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic