Brigit Surgical Device
FDA 510(k) K060556 · Zimmer, Inc.
510(k) numberK060556
Submission
- Device name
- Brigit Surgical Device
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- March 2, 2006
- Decision date
- July 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Brigit Surgical Device cleared by the FDA?
Brigit Surgical Device (K060556) received a 510(k) decision of Substantially Equivalent on July 31, 2006, 151 days after the submission was received.
What is the product code of K060556?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.