FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
K Number: K090374
·
Decision Mar 11, 2009
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
56
Applicant Total
207
Review Days
22
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Basic Information
- Device Name
- STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
- K Number
- K090374
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- February 17, 2009
- Decision Date
- March 11, 2009
- 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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