FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE ARTHROFILE
K Number: K812506
·
Decision Sep 24, 1981
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
8
Applicant Total
19
Review Days
23
Basic Information
- Device Name
- THE ARTHROFILE
- K Number
- K812506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- DYONICS, INC.
- Date Received
- September 1, 1981
- Decision Date
- September 24, 1981
- Product Code
- HTR
- 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 |
|---|---|---|---|
| HTR | Rasp | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTR), ordered by most recent decision date.
BIODYNAMICS SMALL JOINT BRUSH #1203
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BIODYNAMICS FEMORAL CANAL BRUSH #1201
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ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
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RICHARDS ACETABULAR BRUSH
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MICRO RASPS
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INTERMEDULLARY BRUSH
FDA 510(k)
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·General, Plastic Surgery
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 |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Mar 21, 1988 | Substantially Equivalent |
| K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM | Mar 4, 1988 | Substantially Equivalent |