FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIXATION PIN
K Number: K911452
·
Decision Apr 12, 1991
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
5
Review Days
9
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Basic Information
- Device Name
- FIXATION PIN
- K Number
- K911452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Simpex, Inc.
- Date Received
- April 3, 1991
- Decision Date
- April 12, 1991
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Simpex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920174 | EASY TOUCH LATEX EAM GLOVES | Apr 22, 1992 | Substantially Equivalent |
| K913793 | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | Dec 30, 1991 | Substantially Equivalent |
| K913794 | SIMPEX INC. SURGICAL DRESSING | Nov 20, 1991 | Substantially Equivalent |
| K911505 | FIXATION WIRE | Apr 12, 1991 | Substantially Equivalent |