MALUC Total Hip Arthroplasty System
FDA 510(k) K162125 · Surgtech, Inc.
510(k) numberK162125
Submission
- Device name
- MALUC Total Hip Arthroplasty System
- Applicant
- Surgtech, Inc.
Westlake, OH, US - Received
- August 1, 2016
- Decision date
- May 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
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| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
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| K191192 | SurgTech GENOLL Total Knee SystemJWH · Traditional | 08/01/2019SE |
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| K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemNKB · Traditional | 04/05/2017SE |
| K161894 | SurgTech Trauma SystemHWC · Traditional | 02/21/2017SE |
| K152200 | SurgTech Interbody SystemMAX · Traditional | 03/25/2016SE |
Questions and answers
When was MALUC Total Hip Arthroplasty System cleared by the FDA?
MALUC Total Hip Arthroplasty System (K162125) received a 510(k) decision of Substantially Equivalent on May 10, 2017, 282 days after the submission was received.
What is the product code of K162125?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.