FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AESCULAP BONE MILL
K Number: K860016
·
Decision Mar 19, 1986
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
3
Applicant Total
13
Review Days
75
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Basic Information
- Device Name
- AESCULAP BONE MILL
- K Number
- K860016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Aesculap Instruments Corp.
- Date Received
- January 3, 1986
- Decision Date
- March 19, 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
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ORTHOBLEND POWERED BONE MILL
FDA 510(k)
FDA Class 1
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OSTEOMILL BONE GRINDER
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Aesculap Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K885046 | INSITUCAT VALVE STRIPPER | Feb 28, 1990 | Substantially Equivalent |
| K890182 | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV | Feb 28, 1990 | Substantially Equivalent |
| K890443 | CASPAR SCALP CLIP, APPLIER | Jun 15, 1989 | Substantially Equivalent |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Jun 1, 1989 | Substantially Equivalent |
| K884057 | ELAN-E DISPOSABLE DRAPE | Oct 19, 1988 | Substantially Equivalent |
| K880704 | CERULLO SUCTION REGULATOR | Mar 29, 1988 | Substantially Equivalent |
| K801888 | HANDPIECE, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K801886 | BURR, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K801887 | DRILL, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K792558 | CONTAINER SYSTEM | Dec 27, 1979 | Substantially Equivalent |