The following data is part of a premarket notification filed by Elite Surgical Supplies (pty) Ltd. with the FDA for Vertefix Pedicle Screw Spinal System.
Device ID | K063453 |
510k Number | K063453 |
Device Name: | VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE I Marietta, GA 30060 |
Contact | Charise De Barrios |
Correspondent | Charise De Barrios ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE I Marietta, GA 30060 |
Product Code | MNI |
Subsequent Product Code | KWP |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-15 |
Decision Date | 2007-08-30 |
Summary: | summary |