The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Brainlab Trauma Compatible Instruments.
Device ID | K111891 |
510k Number | K111891 |
Device Name: | SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester, PA 19380 |
Contact | Christopher Hack |
Correspondent | Christopher Hack SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester, PA 19380 |
Product Code | HSB |
Subsequent Product Code | HRS |
Subsequent Product Code | KTT |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-05 |
Decision Date | 2011-11-28 |
Summary: | summary |