Acumen Surgical Navigation System
FDA 510(k) K031454 · Biomet, Inc.
510(k) numberK031454
Submission
- Device name
- Acumen Surgical Navigation System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- May 7, 2003
- Decision date
- July 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Acumen Surgical Navigation System cleared by the FDA?
Acumen Surgical Navigation System (K031454) received a 510(k) decision of Substantially Equivalent on July 8, 2004, 428 days after the submission was received.
What is the product code of K031454?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.