FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACER BONE MILL
K Number: K883183
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
3
Applicant Total
3
Review Days
76
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Basic Information
- Device Name
- TRACER BONE MILL
- K Number
- K883183
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- De Medica Mfg., Inc.
- Date Received
- July 28, 1988
- Decision Date
- October 12, 1988
- Product Code
- LYS
- 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 |
|---|---|---|---|
| LYS | Bone Mill | FDA class 1 | Orthopedic |
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