Excia Total Hip System Lateral Offset
FDA 510(k) K061344 · Aesculap, Inc.
510(k) numberK061344
Submission
- Device name
- Excia Total Hip System Lateral Offset
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- May 15, 2006
- Decision date
- August 2, 2006
- 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 Excia Total Hip System Lateral Offset cleared by the FDA?
Excia Total Hip System Lateral Offset (K061344) received a 510(k) decision of Substantially Equivalent on August 2, 2006, 79 days after the submission was received.
What is the product code of K061344?
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.