FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
K Number: K030096
·
Decision Mar 18, 2003
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
181
Review Days
67
Basic Information
- Device Name
- VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
- K Number
- K030096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ARTHREX, INC.
- Date Received
- January 10, 2003
- Decision Date
- March 18, 2003
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Arthrex Spine Endoscope
FDA 510(k)
FDA Class 2
·Orthopedic
VECTR Video Endoscopic Carpal Tunnel Release System
FDA 510(k)
FDA Class 2
·Orthopedic
MIDASVu
FDA 510(k)
FDA Class 2
·Orthopedic
Vertos mild Device Kit (MDK-0002)
FDA 510(k)
FDA Class 2
·Orthopedic
Digital ClarusScope System; Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
FMS VUE Fluid Management and Tissue Debridement System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by ARTHREX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K170206 | Arthrex FiberTape Cerclage | Nov 15, 2017 | Substantially Equivalent |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Nov 21, 2016 | Substantially Equivalent |
| K161581 | Arthrex Synergy RF System | Sep 9, 2016 | Substantially Equivalent |
| K161108 | Arthrex VaultLock Glenoid | Aug 29, 2016 | Substantially Equivalent |
| K160319 | FiberTak DR | May 10, 2016 | Substantially Equivalent |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Apr 19, 2016 | Substantially Equivalent |
| K151342 | Arthrex SwiveLock Anchors | Mar 24, 2016 | Substantially Equivalent |
| K153218 | Arthrex Synergy UHD4 System | Feb 12, 2016 | Substantially Equivalent |
| K153115 | Arthrex Univers Apex, Size 5 Stem | Nov 23, 2015 | Substantially Equivalent |
| K152252 | Arthrex iBalance TKA System | Nov 16, 2015 | Substantially Equivalent |