FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoPlan System
K Number: K212570
·
Decision Feb 11, 2022
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
5
Review Days
179
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Basic Information
- Device Name
- OsteoPlan System
- K Number
- K212570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed, LLC
- Date Received
- August 16, 2021
- Decision Date
- February 11, 2022
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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Other Clearances by Osteomed, LLC
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | Apr 4, 2017 | Substantially Equivalent |