Acetabular Shells & Liners for Ath Total Hip Syst.
FDA 510(k) K893821 · Kinamed, Inc.
510(k) numberK893821
Submission
- Device name
- Acetabular Shells & Liners for Ath Total Hip Syst.
- Applicant
- Kinamed, Inc.
Los Angeles, CA, US - Received
- May 23, 1989
- Decision date
- November 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Acetabular Shells & Liners for Ath Total Hip Syst. cleared by the FDA?
Acetabular Shells & Liners for Ath Total Hip Syst. (K893821) received a 510(k) decision of Substantially Equivalent on November 6, 1989, 167 days after the submission was received.
What is the product code of K893821?
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.