FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VERTEBRAL ACCESS SYSTEM BY VIDACARE
K Number: K081713
·
Decision Nov 21, 2008
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
2
Applicant Total
19
Review Days
157
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Basic Information
- Device Name
- VERTEBRAL ACCESS SYSTEM BY VIDACARE
- K Number
- K081713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vidacare Corporation
- Date Received
- June 17, 2008
- Decision Date
- November 21, 2008
- Product Code
- MOQ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MOQ | Battery, Replacement, Rechargeable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOQ), ordered by most recent decision date.
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Vidacare Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | Feb 11, 2014 | Substantially Equivalent |
| K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE | Jun 3, 2012 | Substantially Equivalent |
| K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE | Mar 8, 2012 | Substantially Equivalent |
| K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO | Jul 27, 2010 | Substantially Equivalent |
| K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO | Oct 14, 2009 | Substantially Equivalent |
| K072045 | ONCONTROL BONE MARROW BIOPSY SYSTEM | Oct 22, 2007 | Substantially Equivalent |
| K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | May 21, 2007 | Substantially Equivalent |
| K063567 | EZ-MIO STERNAL | Jan 26, 2007 | Substantially Equivalent |
| K063142 | MANUAL PD-IO; POWERED PD-IO | Dec 8, 2006 | Substantially Equivalent |
| K062956 | EZ-MIO, EZ-IO DISTAL TIBIA | Dec 5, 2006 | Substantially Equivalent |