FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoMed ExtremiFix Mid and Large Screw System
K Number: K163303
·
Decision Apr 4, 2017
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
5
Review Days
133
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Basic Information
- Device Name
- OsteoMed ExtremiFix Mid and Large Screw System
- K Number
- K163303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed, LLC
- Date Received
- November 22, 2016
- Decision Date
- April 4, 2017
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Osteomed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K212570 | OsteoPlan System | Feb 11, 2022 | Substantially Equivalent |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Oct 29, 2020 | Substantially Equivalent |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | Oct 15, 2020 | Substantially Equivalent |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | May 10, 2018 | Substantially Equivalent |