FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K Number: K163046
·
Decision Feb 9, 2017
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
19
Review Days
100
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
- DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
- K Number
- K163046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Synthes
- Date Received
- November 1, 2016
- Decision Date
- February 9, 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
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 DePuy Synthes
| K Number | Device Name | ||
|---|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | Aug 1, 2024 | Substantially Equivalent |
| K233255 | CROSSNAV Navigation Enabled Instruments | Jun 17, 2024 | Substantially Equivalent |
| K233256 | Robotic Integration Instruments | Jun 17, 2024 | Substantially Equivalent |
| K233254 | TELIGEN System Navigation Ready Instruments | Jun 14, 2024 | Substantially Equivalent |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | Mar 21, 2024 | Substantially Equivalent |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | Jul 26, 2023 | Substantially Equivalent |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | Sep 20, 2022 | Substantially Equivalent |
| K213563 | DePuy Synthes Radial Head Replacement System | Mar 18, 2022 | Substantially Equivalent |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | Jun 2, 2021 | Substantially Equivalent |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | Dec 16, 2020 | Substantially Equivalent |