FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
K Number: K902053
·
Decision Sep 14, 1990
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
8
Applicant Total
4
Review Days
130
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Basic Information
- Device Name
- K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
- K Number
- K902053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Westcon Orthopedics, Inc.
- Date Received
- May 7, 1990
- Decision Date
- September 14, 1990
- Product Code
- LYT
- 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 |
|---|---|---|---|
| LYT | Fixation Accessory | FDA class 2 | Orthopedic |
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