The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif.
Device ID | K130573 |
510k Number | K130573 |
Device Name: | TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960 |
Contact | Jeff Tyber |
Correspondent | Jeff Tyber TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-04 |
Decision Date | 2013-09-30 |
Summary: | summary |