FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K Number: K950384
·
Decision May 22, 1995
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
56
Applicant Total
402
Review Days
110
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Basic Information
- Device Name
- SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
- K Number
- K950384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- February 1, 1995
- Decision Date
- May 22, 1995
- Product Code
- LXT
- 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 |
|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | FDA class 2 | Orthopedic |
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| K103002 | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM | Mar 2, 2011 | Substantially Equivalent |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Jan 21, 2011 | Substantially Equivalent |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Dec 16, 2010 | Substantially Equivalent |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES | Dec 9, 2010 | Substantially Equivalent |
| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 3, 2010 | Substantially Equivalent |