The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) (synthes) Low Profile Neuro System.
| Device ID | K042986 |
| 510k Number | K042986 |
| Device Name: | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM |
| Classification | Cover, Burr Hole |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-29 |
| Decision Date | 2004-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804215540 | K042986 | 000 |
| H9804215530 | K042986 | 000 |