FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K Number: K051815
·
Decision Oct 17, 2005
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
11
Review Days
104
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Basic Information
- Device Name
- MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
- K Number
- K051815
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vertebron, Inc.
- Date Received
- July 5, 2005
- Decision Date
- October 17, 2005
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Vertebron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | Jul 3, 2008 | Substantially Equivalent |
| K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Jul 2, 2008 | Substantially Equivalent |
| K073502 | VERTEBRON VBR SYSTEM | Mar 24, 2008 | Substantially Equivalent |
| K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Jun 13, 2007 | Substantially Equivalent |
| K062110 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Aug 16, 2006 | Substantially Equivalent |
| K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Sep 7, 2005 | Substantially Equivalent |
| K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Feb 1, 2005 | Substantially Equivalent |
| K043181 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | Dec 17, 2004 | Substantially Equivalent |
| K040003 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Mar 26, 2004 | Substantially Equivalent |
| K033352 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Feb 25, 2004 | Substantially Equivalent |