The following data is part of a premarket notification filed by T.a.g. Medical Products with the FDA for Latarjet Cortical Screw Set.
Device ID | K083096 |
510k Number | K083096 |
Device Name: | LATARJET CORTICAL SCREW SET |
Classification | Screw, Fixation, Bone |
Applicant | T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset, MA 02726 |
Contact | George J Hattub |
Correspondent | George J Hattub T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset, MA 02726 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-17 |
Decision Date | 2009-04-17 |
Summary: | summary |