FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
K Number: K983814
·
Decision Jan 14, 1999
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
22
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
- K Number
- K983814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Efratgo, Ltd. HI Tech Bio-Surgical
- Date Received
- October 28, 1998
- Decision Date
- January 14, 1999
- Product Code
- JDO
- 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 |
|---|---|---|---|
| JDO | Device, Fixation, Proximal Femoral, Implant | FDA class 2 | Orthopedic |
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