The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 4.0/2.5 Mm Self-drilling Schanz Screw.
Device ID | K002605 |
510k Number | K002605 |
Device Name: | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW |
Classification | Pin, Fixation, Threaded |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Bonnie J Smith |
Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-22 |
Decision Date | 2000-11-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6792947690 | K002605 | 000 |
H6794947690 | K002605 | 000 |