FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SINGLE LEG MAYFIELD TABLE
K Number: K851022
·
Decision Apr 17, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
19
Review Days
36
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Basic Information
- Device Name
- SINGLE LEG MAYFIELD TABLE
- K Number
- K851022
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Instrument Co., Inc.
- Date Received
- March 12, 1985
- Decision Date
- April 17, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Ohio Medical Instrument Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | Jul 29, 2002 | Substantially Equivalent |
| K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM | Apr 4, 2002 | Substantially Equivalent |
| K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F | Nov 2, 1999 | Substantially Equivalent |
| K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A | Jul 12, 1999 | Substantially Equivalent |
| K983282 | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 | Nov 19, 1998 | Substantially Equivalent |
| K982244 | MAYFIELD ACCISS OPTICAL SYSTEM | Sep 23, 1998 | Substantially Equivalent |
| K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 | May 17, 1996 | Substantially Equivalent |
| K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP | Feb 9, 1996 | Substantially Equivalent |
| K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN | Dec 6, 1995 | Substantially Equivalent |
| K934289 | MAYFIELD RADIOLUCENT SKULL CLAMP | Jan 7, 1994 | Substantially Equivalent |