FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
K Number: K161863
·
Decision Nov 23, 2016
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
186
Applicant Total
42
Review Days
140
Basic Information
- Device Name
- ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
- K Number
- K161863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker GmbH
- Date Received
- July 6, 2016
- Decision Date
- November 23, 2016
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWS), ordered by most recent decision date.
MyShoulder Planner (5.3SSWPL)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS)
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Univers Apex OptiFit Humeral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
AltiVate® Anatomic Shoulder AG e+ with Markers
FDA 510(k)
FDA Class 2
·Orthopedic
AETOS Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Stryker GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Oct 6, 2024 | Substantially Equivalent |
| K233919 | VariAx 2 Distal Radius System | Mar 25, 2024 | Substantially Equivalent |
| K233741 | Hoffmann LRF System | Dec 21, 2023 | Substantially Equivalent |
| K231257 | Pangea Utility Plating System, Pangea Platform | Aug 18, 2023 | Substantially Equivalent |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Aug 18, 2023 | Substantially Equivalent |
| K230512 | Gamma4 System | Jun 9, 2023 | Substantially Equivalent |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Apr 27, 2023 | Substantially Equivalent |
| K221346 | Stryker VariAx 2 MIS Calcaneus | Jul 8, 2022 | Substantially Equivalent |
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Jun 10, 2022 | Substantially Equivalent |
| K210582 | EasyClip® and EasyClip® Xpress | Jun 10, 2022 | Substantially Equivalent |