FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HALL STERNUM SAW
K Number: K862474
·
Decision Jul 17, 1986
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
3
Applicant Total
8
Review Days
17
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Basic Information
- Device Name
- HALL STERNUM SAW
- K Number
- K862474
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Hall Surgical, Division of Zimmer, Inc.
- Date Received
- June 30, 1986
- Decision Date
- July 17, 1986
- Product Code
- DWH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| DWH | Blade, Saw, Surgical, Cardiovascular | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWH), ordered by most recent decision date.
CODMAN COLLINS RADIOPARENT STERNAL BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARDIOVASCULAR SAW BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K864163 | HALL DUNBAR DRILL GUIDE SYSTEM | Nov 20, 1986 | Substantially Equivalent |
| K862778 | HALL CANNLULA SYSTEM | Sep 8, 1986 | Substantially Equivalent |
| K862529 | HALL STERILE BUR | Jul 15, 1986 | Substantially Equivalent |
| K852143 | HALL IRRIGATION SYSTEM | Jun 26, 1985 | Substantially Equivalent |