FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
K Number: K862945
·
Decision Aug 20, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
60
Review Days
15
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Basic Information
- Device Name
- DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
- K Number
- K862945
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Downs Surgical , Ltd.
- Date Received
- August 5, 1986
- Decision Date
- August 20, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Downs Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Oct 31, 1990 | Substantially Equivalent |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Oct 31, 1990 | Substantially Equivalent |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Oct 31, 1990 | Substantially Equivalent |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Oct 31, 1990 | Substantially Equivalent |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Oct 22, 1990 | Substantially Equivalent |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Oct 22, 1990 | Substantially Equivalent |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Oct 22, 1990 | Substantially Equivalent |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Oct 22, 1990 | Substantially Equivalent |
| K900616 | SHEPPERD CUTTING FORCEPS | Oct 22, 1990 | Substantially Equivalent |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Oct 22, 1990 | Substantially Equivalent |