FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Y3 Proximal Femoral Plate System
K Number: K163003
·
Decision Mar 16, 2017
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
12
Review Days
139
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Basic Information
- Device Name
- Y3 Proximal Femoral Plate System
- K Number
- K163003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pega Medical, Inc.
- Date Received
- October 28, 2016
- Decision Date
- March 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
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
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Other Clearances by Pega Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K192710 | The Simple Locking Intramedullary (Slim) System | Jun 24, 2020 | Substantially Equivalent |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Sep 8, 2017 | Substantially Equivalent |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | Nov 23, 2016 | Substantially Equivalent |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | Jul 10, 2015 | Substantially Equivalent |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | Nov 27, 2013 | Substantially Equivalent |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | Jan 26, 2012 | Substantially Equivalent |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | May 20, 2009 | Substantially Equivalent |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | Aug 17, 2004 | Substantially Equivalent |