FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HALL DUNBAR DRILL GUIDE SYSTEM
K Number: K864163
·
Decision Nov 20, 1986
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- HALL DUNBAR DRILL GUIDE SYSTEM
- K Number
- K864163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Hall Surgical, Division of Zimmer, Inc.
- Date Received
- October 23, 1986
- Decision Date
- November 20, 1986
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Hall Surgical, Division of Zimmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM | Sep 7, 1994 | Substantially Equivalent |
| K864734 | HALL ORAL IMPLANT SYSTEM | Feb 10, 1987 | Substantially Equivalent |
| K864929 | HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST | Jan 28, 1987 | Substantially Equivalent |
| K862778 | HALL CANNLULA SYSTEM | Sep 8, 1986 | Substantially Equivalent |
| K862474 | HALL STERNUM SAW | Jul 17, 1986 | Substantially Equivalent |
| K862529 | HALL STERILE BUR | Jul 15, 1986 | Substantially Equivalent |
| K852143 | HALL IRRIGATION SYSTEM | Jun 26, 1985 | Substantially Equivalent |