FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
K Number: K953607
·
Decision Mar 8, 1996
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
22
Applicant Total
402
Review Days
219
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Basic Information
- Device Name
- TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
- K Number
- K953607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- August 2, 1995
- Decision Date
- March 8, 1996
- 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 |
Similar 510(k) Clearances
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