FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAFT HARVESTING SAWBLADES
K Number: K971978
·
Decision Jun 18, 1997
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
302
Review Days
20
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Basic Information
- Device Name
- GRAFT HARVESTING SAWBLADES
- K Number
- K971978
- 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
- Wrightmedicaltechnologyinc
- Date Received
- May 29, 1997
- Decision Date
- June 18, 1997
- Product Code
- GFA
- 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 |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFA), ordered by most recent decision date.
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WRIGHT MEDICAL TECHNOLOGY SAWBLADES
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RE-SHARPENABLE SAW BLADES
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BUR, SURGICAL, GENERAL & PLASTIC SURGERY
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