FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEO Bone Screw System
K Number: K202817
·
Decision Oct 22, 2020
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- GEO Bone Screw System
- K Number
- K202817
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gramercy Extremity Orthopedics, LLC
- Date Received
- September 24, 2020
- Decision Date
- October 22, 2020
- 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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|---|---|---|---|
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| K200108 | GEO 1st MTP Joint Arthrodesis Plating System | Mar 26, 2020 | Substantially Equivalent |
| K182212 | Geo Staple System | Jan 11, 2019 | Substantially Equivalent |