The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.3 Mm Self-drilling Screw.
Device ID | K983485 |
510k Number | K983485 |
Device Name: | SYNTHES 1.3 MM SELF-DRILLING SCREW |
Classification | Screw, Fixation, Intraosseous |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-05 |
Decision Date | 1998-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H980400456E0 | K983485 | 000 |
H980400455E0 | K983485 | 000 |
H980400454E0 | K983485 | 000 |