The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modofocation To Synthes Ankle Arthrodesis Plates.
Device ID | K022255 |
510k Number | K022255 |
Device Name: | MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Matthew M Hull |
Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-12 |
Decision Date | 2002-07-25 |
Summary: | summary |