FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAVERICK External Fixation System
K Number: K213874
·
Decision Feb 11, 2022
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
529
Review Days
60
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Basic Information
- Device Name
- MAVERICK External Fixation System
- K Number
- K213874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- December 13, 2021
- Decision Date
- February 11, 2022
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
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