FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StealthFix Intraosseous Fixation System
K Number: K220181
·
Decision Mar 22, 2022
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
17
Review Days
60
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Basic Information
- Device Name
- StealthFix Intraosseous Fixation System
- K Number
- K220181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nextremity Solutions, Inc.
- Date Received
- January 21, 2022
- Decision Date
- March 22, 2022
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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