The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes 3.5mm Low Profile Cortical Screw.
Device ID | K111230 |
510k Number | K111230 |
Device Name: | SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW |
Classification | Screw, Fixation, Bone |
Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
Contact | Rebecca Blank |
Correspondent | Rebecca Blank SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-02 |
Decision Date | 2011-05-24 |
Summary: | summary |