FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
K Number: K201660
·
Decision Jul 16, 2020
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
19
Applicant Total
15
Review Days
28
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Basic Information
- Device Name
- KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K Number
- K201660
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kyocera Medical Technologies, Inc.
- Date Received
- June 18, 2020
- Decision Date
- July 16, 2020
- Product Code
- OQG
- 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 |
|---|---|---|---|
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | FDA class 2 | Orthopedic |
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