FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
EPI-UNION PLATING SYSTEM
K Number: K974289
·
Decision Feb 12, 1998
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
36
Review Days
90
Basic Information
- Device Name
- EPI-UNION PLATING SYSTEM
- K Number
- K974289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- HOWMEDICA, INC.
- Date Received
- November 14, 1997
- Decision Date
- February 12, 1998
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K982463 | EXTRACRANIAL RADIOTHERAPY SYSTEM | Sep 30, 1998 | Substantially Equivalent |
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| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent |
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