The following data is part of a premarket notification filed by Stryker with the FDA for Navigation Enabled Instruments.
| Device ID | K183381 |
| 510k Number | K183381 |
| Device Name: | Navigation Enabled Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | STRYKER 2 Pearl Court Allendale, NJ 07401 |
| Contact | Megan Callanan |
| Correspondent | Megan Callanan STRYKER 2 Pearl Court Allendale, NJ 07401 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-05-17 |
| Summary: | summary |