K153396 is an FDA 510(k) clearance for the Aesculap OrthoPilot Next Generation. This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on May 16, 2016, 174 days after receiving the submission on November 24, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K153396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2015 |
| Decision Date | May 16, 2016 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO — Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |