FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
K Number: K172189
·
Decision Jan 16, 2018
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
5
Review Days
180
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Basic Information
- Device Name
- Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
- K Number
- K172189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Truemed Group, LLC
- Date Received
- July 20, 2017
- Decision Date
- January 16, 2018
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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Other Clearances by Truemed Group, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K200575 | TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM | Jul 9, 2021 | Substantially Equivalent |
| K182650 | Arzzt Distal Radius and Ulna System | Jun 10, 2019 | Substantially Equivalent |
| K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | Aug 3, 2017 | Substantially Equivalent |
| K133166 | INS HILDEN TIBIAL ARZZT | Nov 6, 2014 | Substantially Equivalent |