FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXACTECH STERILE MODULAR DRILL BIT
K Number: K960720
·
Decision Apr 23, 1996
Classifications
1
FEI Numbers
387
Registration Numbers
387
Same Product Code
75
Applicant Total
186
Review Days
61
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Basic Information
- Device Name
- EXACTECH STERILE MODULAR DRILL BIT
- K Number
- K960720
- 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
- Exactech, Inc.
- Date Received
- February 22, 1996
- Decision Date
- April 23, 1996
- Product Code
- HWE
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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