Hemi-Arc Surgical Navigator
FDA 510(k) K013257 · Nuvasive, Inc.
510(k) numberK013257
Submission
- Device name
- Hemi-Arc Surgical Navigator
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- October 1, 2001
- Decision date
- October 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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 Hemi-Arc Surgical Navigator cleared by the FDA?
Hemi-Arc Surgical Navigator (K013257) received a 510(k) decision of Substantially Equivalent on October 30, 2001, 29 days after the submission was received.
What is the product code of K013257?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.