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 |