The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZ
FDA 510(k) K992409 · Implex Corp.
510(k) numberK992409
Submission
- Device name
- The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZ
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- July 20, 1999
- Decision date
- October 8, 1999
- 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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Questions and answers
When was The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZ cleared by the FDA?
The Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZ (K992409) received a 510(k) decision of Substantially Equivalent on October 8, 1999, 80 days after the submission was received.
What is the product code of K992409?
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.