FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K Number: K012738
·
Decision Nov 14, 2001
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
48
Review Days
90
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Basic Information
- Device Name
- SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
- K Number
- K012738
- 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
- Depuyacromed
- Date Received
- August 16, 2001
- Decision Date
- November 14, 2001
- Product Code
- GEY
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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| K030249 | SURGICAL TITANIUM MESH SYSTEM | Feb 14, 2003 | Substantially Equivalent |
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| 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 |