The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Invisx Cranial Fixation System, Model 60100-60900.
| Device ID | K010361 |
| 510k Number | K010361 |
| Device Name: | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 |
| Classification | Cover, Burr Hole |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Carol Baccash |
| Correspondent | Carol Baccash MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-06 |
| Decision Date | 2001-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40613994845021 | K010361 | 000 |
| 00681490881555 | K010361 | 000 |
| 00681490881579 | K010361 | 000 |
| 00643169466296 | K010361 | 000 |
| 20643169466306 | K010361 | 000 |
| 40643169496970 | K010361 | 000 |
| 00643169497771 | K010361 | 000 |
| 00643169497788 | K010361 | 000 |
| 00643169498006 | K010361 | 000 |
| 00643169498242 | K010361 | 000 |
| 00643169103467 | K010361 | 000 |
| 00681490881470 | K010361 | 000 |