FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K Number: K040197
·
Decision Apr 2, 2004
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
48
Review Days
64
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Basic Information
- Device Name
- EAGLE ANTERIOR CERVIAL PLATE SYSTEM
- K Number
- K040197
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuyacromed
- Date Received
- January 29, 2004
- Decision Date
- April 2, 2004
- 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 |
Similar 510(k) Clearances
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Other Clearances by Depuyacromed
| K Number | Device Name | ||
|---|---|---|---|
| K031635 | DEPUY ACROMED VBR SYSTEM | Jun 23, 2003 | Substantially Equivalent |
| K030833 | DEPUY ACROMED VBR SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS | Feb 26, 2003 | Substantially Equivalent |
| K030249 | SURGICAL TITANIUM MESH SYSTEM | Feb 14, 2003 | Substantially Equivalent |
| K030103 | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS | Feb 5, 2003 | Substantially Equivalent |
| K023835 | DEVEX MESH SYSTEM | Jan 29, 2003 | Substantially Equivalent |
| K024348 | MONARCH SPINE SYSTEM | Jan 28, 2003 | Substantially Equivalent |
| K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT | Jan 23, 2003 | Substantially Equivalent |
| K021039 | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM | Dec 11, 2002 | Substantially Equivalent |
| K023438 | MODIFICATION TO MONARCH SPINE SYSTEM | Nov 13, 2002 | Substantially Equivalent |