K012938 is an FDA 510(k) clearance for the SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 8, 2002, 161 days after receiving the submission on August 31, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K012938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2001 |
| Decision Date | February 08, 2002 |
| Days to Decision | 161 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |