FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TiN Coated Humeral Head
K Number: K191698
·
Decision Jul 16, 2020
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
11
Review Days
387
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Basic Information
- Device Name
- TiN Coated Humeral Head
- K Number
- K191698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fx Shoulder USA, Inc.
- Date Received
- June 25, 2019
- Decision Date
- July 16, 2020
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Fx Shoulder USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K223801 | FX V135(TM) Shoulder Prosthesis | Jun 5, 2023 | Substantially Equivalent |
| K222936 | Humeris® 135 Shoulder System | Nov 7, 2022 | Substantially Equivalent |
| K213117 | FX V135 Shoulder Prosthesis | Jun 7, 2022 | Substantially Equivalent |
| K210790 | Lateralized and Augmented Baseplates | Aug 25, 2021 | Substantially Equivalent |
| K201391 | Easytech® Anatomical Shoulder System | Feb 16, 2021 | Substantially Equivalent |
| K191146 | Humelock TiN Coated Glenosphere | Jul 15, 2020 | Substantially Equivalent |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Apr 29, 2020 | Substantially Equivalent |
| K192799 | Glenoid Baseplate with Screw | Feb 21, 2020 | Substantially Equivalent |
| K192206 | 32mm Glenosphere and Humeral Cup | Oct 8, 2019 | Substantially Equivalent |