FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CABLE-EASE PLATE AND CABLE SYSTEM
K Number: K944529
·
Decision Feb 17, 1995
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
127
Applicant Total
108
Review Days
155
Basic Information
- Device Name
- CABLE-EASE PLATE AND CABLE SYSTEM
- K Number
- K944529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- INTERMEDICS ORTHOPEDICS
- Date Received
- September 15, 1994
- Decision Date
- February 17, 1995
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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