The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Trochanter Stabilization Plate For Dhs.
Device ID | K000972 |
510k Number | K000972 |
Device Name: | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
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 | LXT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-27 |
Decision Date | 2000-06-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679281870S0 | K000972 | 000 |
H6792818700 | K000972 | 000 |