FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K Number: K001105
·
Decision Apr 24, 2000
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
48
Review Days
19
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Basic Information
- Device Name
- MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
- K Number
- K001105
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuyacromed
- Date Received
- April 5, 2000
- Decision Date
- April 24, 2000
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Depuyacromed
| K Number | Device Name | ||
|---|---|---|---|
| K040197 | EAGLE ANTERIOR CERVIAL PLATE SYSTEM | Apr 2, 2004 | Substantially Equivalent |
| 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 |