Depuy Cas Hip Instrumentation
FDA 510(k) K052178 · DePuy Orthopaedics, Inc.
510(k) numberK052178
Submission
- Device name
- Depuy Cas Hip Instrumentation
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- August 10, 2005
- Decision date
- October 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Depuy Cas Hip Instrumentation cleared by the FDA?
Depuy Cas Hip Instrumentation (K052178) received a 510(k) decision of Substantially Equivalent on October 21, 2005, 72 days after the submission was received.
What is the product code of K052178?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.