FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EQUESTRA FLUID DELIVERY SYSTEM
K Number: K040483
·
Decision Jul 23, 2004
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
99
Review Days
149
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
- EQUESTRA FLUID DELIVERY SYSTEM
- K Number
- K040483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date Received
- February 25, 2004
- Decision Date
- July 23, 2004
- 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.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medtronic Sofamor Danek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | Jun 12, 2025 | Substantially Equivalent |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Jan 17, 2025 | Substantially Equivalent |
| K230716 | Robotic Graft Delivery Instruments | Jul 18, 2023 | Substantially Equivalent |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Sep 5, 2014 | Substantially Equivalent |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | Jul 9, 2014 | Substantially Equivalent |
| K140449 | CD HORIZON SPINAL SYSTEM | Mar 25, 2014 | Substantially Equivalent |
| K132897 | CLYDESDALE SPINAL SYSTEM | Dec 11, 2013 | Substantially Equivalent |
| K133216 | CRESCENT SPINAL SYSTEM | Nov 22, 2013 | Substantially Equivalent |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Sep 26, 2013 | Substantially Equivalent |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | Sep 23, 2013 | Substantially Equivalent |