FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHOBLEND POWERED BONE MILL
K Number: K860356
·
Decision Jul 8, 1986
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
3
Applicant Total
376
Review Days
159
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Basic Information
- Device Name
- ORTHOBLEND POWERED BONE MILL
- K Number
- K860356
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Zimmer, Inc.
- Date Received
- January 30, 1986
- Decision Date
- July 8, 1986
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYS), ordered by most recent decision date.
TRACER BONE MILL
FDA 510(k)
FDA Class 1
·Orthopedic
OSTEOMILL BONE GRINDER
FDA 510(k)
FDA Class 1
·Orthopedic
AESCULAP BONE MILL
FDA 510(k)
FDA Class 1
·Orthopedic
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