FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Monkey RingsTM External Fixation System
K Number: K232838
·
Decision Oct 12, 2023
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
34
Review Days
28
Basic Information
- Device Name
- Monkey RingsTM External Fixation System
- K Number
- K232838
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- September 14, 2023
- Decision Date
- October 12, 2023
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Paragon 28, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K234128 | Phantom Fibula Nail System | Aug 22, 2024 | Substantially Equivalent |
| K241864 | Grappler Interference Screw System | Jul 25, 2024 | Substantially Equivalent |
| K240259 | APEX 3D Total Ankle Replacement System | Jun 24, 2024 | Substantially Equivalent |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Jun 5, 2024 | Substantially Equivalent |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Mar 26, 2024 | Substantially Equivalent |
| K231867 | Grappler Suture Anchor System | Aug 21, 2023 | Substantially Equivalent |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Mar 3, 2023 | Substantially Equivalent |
| K223056 | JAWS Nitinol Staple System | Feb 16, 2023 | Substantially Equivalent |