The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Remote Surgical Planning System.
| Device ID | K004027 |
| 510k Number | K004027 |
| Device Name: | STRYKER REMOTE SURGICAL PLANNING SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,, MI 49001 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,, MI 49001 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-27 |
| Decision Date | 2001-01-24 |