FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIAX 2 SYSTEM
K Number: K140376
·
Decision Apr 3, 2014
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
25
Review Days
48
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Basic Information
- Device Name
- VARIAX 2 SYSTEM
- K Number
- K140376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Trauma AG
- Date Received
- February 14, 2014
- Decision Date
- April 3, 2014
- 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 Stryker Trauma AG
| K Number | Device Name | ||
|---|---|---|---|
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| K153154 | Asnis JFX System | Dec 28, 2015 | Substantially Equivalent |
| K151178 | VariAx 2 Wrist Fusion System | Jun 24, 2015 | Substantially Equivalent |
| 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 |