The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes In-situ Bender/cutter.
Device ID | K021458 |
510k Number | K021458 |
Device Name: | SYNTHES IN-SITU BENDER/CUTTER |
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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-07 |
Decision Date | 2002-07-24 |
Summary: | summary |