FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYONICS DRILL GUIDE/ISOMETER SYSTEM
K Number: K880739
·
Decision Mar 21, 1988
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
7
Applicant Total
19
Review Days
26
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Basic Information
- Device Name
- DYONICS DRILL GUIDE/ISOMETER SYSTEM
- K Number
- K880739
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dyonics, Inc.
- Date Received
- February 24, 1988
- Decision Date
- March 21, 1988
- Product Code
- LXI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LXI | Guide, Drill, Ligament | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Dyonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900070 | MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM | Feb 16, 1990 | Substantially Equivalent |
| K896416 | DYONICS SHOULDER PORTAL SYSTEM | Jan 2, 1990 | Substantially Equivalent |
| K893136 | SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY | Dec 14, 1989 | Substantially Equivalent |
| K890665 | MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES | Nov 3, 1989 | Substantially Equivalent |
| K894728 | DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE | Aug 18, 1989 | Substantially Equivalent |
| K892062 | PS3500 ARTHROSCOPIC SURGICAL SYSTEM | Jun 23, 1989 | Substantially Equivalent |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | Dec 7, 1988 | Substantially Equivalent |
| K881876 | DYNAMIC CRUCIATE TESTER | Nov 17, 1988 | Substantially Equivalent |
| K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM | Mar 4, 1988 | Substantially Equivalent |
| K870212 | ARTHROSCOPIC SHOULDER HOLDER | Feb 20, 1987 | Substantially Equivalent |