FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Minimally Invasive Bunion Plating System
K Number: K172178
·
Decision Nov 16, 2017
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
14
Review Days
120
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Basic Information
- Device Name
- Minimally Invasive Bunion Plating System
- K Number
- K172178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trilliant Surgical, Ltd.
- Date Received
- July 19, 2017
- Decision Date
- November 16, 2017
- 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 |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Trilliant Surgical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K162354 | Sniper Staple System | Apr 20, 2017 | Substantially Equivalent |
| K160177 | Gridlock Ankle Plating System | Apr 22, 2016 | Substantially Equivalent |
| K153338 | Tiger Cannulated Screw System | Jan 14, 2016 | Substantially Equivalent |
| K130964 | GRIDLOCK PLATING SYSTEM | May 8, 2013 | Substantially Equivalent |
| K123525 | GRIDLOCK PLATING SYSTEM | Feb 15, 2013 | Substantially Equivalent |
| K122959 | HAMMER TOE IMPLANT | Nov 7, 2012 | Substantially Equivalent |
| K121452 | GRIDLOCK PLATING SYSTEM | Aug 20, 2012 | Substantially Equivalent |
| K121008 | TRILLIANT SURGICAL K-WIRES | Jun 4, 2012 | Substantially Equivalent |
| K111834 | DISCO SUBTALAR IMPLANT | Dec 6, 2011 | Substantially Equivalent |
| K112737 | TIGER HEADLESS CANNULATED SCREWS | Oct 20, 2011 | Substantially Equivalent |