FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES PILON PLATE
K Number: K020602
·
Decision May 20, 2002
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
11
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SYNTHES PILON PLATE
- K Number
- K020602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes
- Date Received
- February 22, 2002
- Decision Date
- May 20, 2002
- 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
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
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
FDA 510(k)
FDA Class 2
·Orthopedic
Exalta Proximal Tibia Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
APTUS Clavicle System 2.8
FDA 510(k)
FDA Class 2
·Orthopedic
Pectus Blu System
FDA 510(k)
FDA Class 2
·Orthopedic
Xpert PFP
FDA 510(k)
FDA Class 2
·Orthopedic
Avanti Distal Elbow ORIF System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Synthes
| K Number | Device Name | ||
|---|---|---|---|
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | Sep 5, 2013 | Substantially Equivalent |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | Apr 11, 2013 | Substantially Equivalent |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Jan 9, 2012 | Substantially Equivalent |
| K110604 | VBB SYSTEM | Dec 13, 2011 | Substantially Equivalent |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | Mar 29, 2010 | Substantially Equivalent |
| K013072 | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) | Nov 26, 2002 | Substantially Equivalent |
| K010108 | USS-LINE EXTENSION | Jun 6, 2001 | Substantially Equivalent |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | May 29, 2001 | Substantially Equivalent |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | Oct 30, 2000 | Substantially Equivalent |
| K982732 | SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) | Oct 8, 1998 | Substantially Equivalent |