CRW Stereotactic System
FDA 510(k) K160811 · Integra LifeSciences Corporation
510(k) numberK160811
Submission
- Device name
- CRW Stereotactic System
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- March 24, 2016
- Decision date
- December 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
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| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
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Questions and answers
When was CRW Stereotactic System cleared by the FDA?
CRW Stereotactic System (K160811) received a 510(k) decision of Substantially Equivalent on December 6, 2016, 257 days after the submission was received.
What is the product code of K160811?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.