The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton(r) Tl Interbody Fusion Device.
Device ID | K140055 |
510k Number | K140055 |
Device Name: | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | TITAN SPINE, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
Contact | Christine Scifert |
Correspondent | Christine Scifert TITAN SPINE, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-10 |
Decision Date | 2014-07-02 |
Summary: | summary |