100KGY E-Poly Acetabular Liners-Additional Profiles
FDA 510(k) K070399 · Biomet Manufacturing, Inc.
510(k) numberK070399
Submission
- Device name
- 100KGY E-Poly Acetabular Liners-Additional Profiles
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- February 12, 2007
- Decision date
- May 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 100KGY E-Poly Acetabular Liners-Additional Profiles cleared by the FDA?
100KGY E-Poly Acetabular Liners-Additional Profiles (K070399) received a 510(k) decision of Substantially Equivalent on May 4, 2007, 81 days after the submission was received.
What is the product code of K070399?
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.