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 |