FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Klassic HD® Hip System
K Number: K180929
·
Decision May 9, 2018
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
21
Review Days
30
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Basic Information
- Device Name
- Klassic HD® Hip System
- K Number
- K180929
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Total Joint Orthopedics, Inc.
- Date Received
- April 9, 2018
- Decision Date
- May 9, 2018
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Total Joint Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220483 | Platform® Acetabular System | Sep 23, 2022 | Substantially Equivalent |
| K211877 | Klassic Knee System | Jun 22, 2022 | Substantially Equivalent |
| K211602 | Klassic Knee System | Jul 23, 2021 | Substantially Equivalent |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | Oct 9, 2020 | Substantially Equivalent |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | Mar 29, 2019 | Substantially Equivalent |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Mar 15, 2019 | Substantially Equivalent |
| K180159 | Klassic® Knee System | Mar 9, 2018 | Substantially Equivalent |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | Oct 27, 2017 | Substantially Equivalent |
| K162422 | Klassic Knee System | Oct 28, 2016 | Substantially Equivalent |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | Oct 27, 2016 | Substantially Equivalent |