The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Expedium, Viper. Viper 2 Spine System.
Device ID | K131802 |
510k Number | K131802 |
Device Name: | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM |
Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
Applicant | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Contact | Kirsten Lehmuller |
Correspondent | Kirsten Lehmuller DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Product Code | OSH |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-19 |
Decision Date | 2013-09-12 |
Summary: | summary |