The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation Spinous Process Clamps.
| Device ID | K211442 |
| 510k Number | K211442 |
| Device Name: | StealthStation Spinous Process Clamps |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Victoria Baldock |
| Correspondent | Victoria Baldock Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000312312 | K211442 | 000 |
| 00763000312305 | K211442 | 000 |
| 00763000312299 | K211442 | 000 |
| 00763000312282 | K211442 | 000 |
| 00763000312275 | K211442 | 000 |
| 00763000554293 | K211442 | 000 |