FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K Number: K172210
·
Decision Oct 2, 2017
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
25
Review Days
70
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Basic Information
- Device Name
- ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K Number
- K172210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Trauma AG
- Date Received
- July 24, 2017
- Decision Date
- October 2, 2017
- 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.
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|---|---|---|---|
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| K143138 | AxSOS 3 Ti Locking Plate System | Dec 22, 2014 | Substantially Equivalent |
| K140961 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | Nov 10, 2014 | Substantially Equivalent |
| K141992 | VARIAX 2 SYSTEM | Aug 7, 2014 | Substantially Equivalent |
| K141677 | VARIAX ELBOW PLATING SYSTEM | Jul 22, 2014 | Substantially Equivalent |
| K141204 | VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM | Jun 20, 2014 | Substantially Equivalent |
| K141121 | AXSOS 3 TI LOCKING PLATE SYSTEM | Jun 20, 2014 | Substantially Equivalent |
| K140565 | VARIAX 2 COMPRESSION PLATING SYSTEM | May 29, 2014 | Substantially Equivalent |
| K140769 | VARIAX 2 SYSTEM | Apr 17, 2014 | Substantially Equivalent |