The following data is part of a premarket notification filed by Stryker Corporate with the FDA for Spinemask Tracker, Spinemap 3d 3.0-software,spinemap 3d 3.0-upgreade, Spinemap 3d 3.0-enable, Spinemap 3d 3.0-sales D.
| Device ID | K141941 |
| 510k Number | K141941 |
| Device Name: | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | STRYKER CORPORATE BOETZINGER STR.41 Freiburg, Baden-wuerttemberg, DE 79111 |
| Contact | Lilian Eckert |
| Correspondent | Becky Ditty Stryker 4100 E. Milham Ave Kalamazoo, MI 49001 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-17 |
| Decision Date | 2014-10-31 |
| Summary: | summary |