FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MALUC Total Hip Arthroplasty System
K Number: K162125
·
Decision May 10, 2017
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
6
Review Days
282
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Basic Information
- Device Name
- MALUC Total Hip Arthroplasty System
- K Number
- K162125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgtech, Inc.
- Date Received
- August 1, 2016
- Decision Date
- May 10, 2017
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Surgtech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K191192 | SurgTech GENOLL Total Knee System | Aug 1, 2019 | Substantially Equivalent |
| K173455 | SurgTech Bipolar Head System | Jun 14, 2018 | Substantially Equivalent |
| K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | Apr 5, 2017 | Substantially Equivalent |
| K161894 | SurgTech Trauma System | Feb 21, 2017 | Substantially Equivalent |
| K152200 | SurgTech Interbody System | Mar 25, 2016 | Substantially Equivalent |