FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Distal Humerus Plating System
K Number: K200367
·
Decision May 14, 2020
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
11
Review Days
90
Basic Information
- Device Name
- Distal Humerus Plating System
- K Number
- K200367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Dynamics, Inc.
- Date Received
- February 14, 2020
- Decision Date
- May 14, 2020
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Skeletal Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K230908 | Hand Trauma Threaded Nail System | Apr 28, 2023 | Substantially Equivalent |
| K220723 | Hand Trauma Screw System | May 12, 2022 | Substantially Equivalent |
| K213895 | Distal Humerus Plating System | Jan 13, 2022 | Substantially Equivalent |
| K211439 | Small Bone Nailing System | Sep 30, 2021 | Substantially Equivalent |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating System | Oct 13, 2020 | Substantially Equivalent |
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| K200538 | Skeletal Dynamics Forearm Plating System | Jun 1, 2020 | Substantially Equivalent |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating System | May 14, 2020 | Substantially Equivalent |