The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Stalif C Flx, Stalif M Flx, Stalif L Flx And Stalif Lateral-oblique Flx, Actilif C Flx, Actilif M Flx, Actilif L Flx And Actilif Lateral-oblique Flx.
Device ID | K173347 |
510k Number | K173347 |
Device Name: | STALIF C FLX, STALIF M FLX, STALIF L FLX And STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX And ACTILIF Lateral-Oblique FLX |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Centinel Spine, Inc. 900 Airport Road, Suite 3B West Chester, PA 19380 |
Contact | Jessica Staub |
Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
Product Code | MAX |
Subsequent Product Code | ODP |
Subsequent Product Code | OVD |
Subsequent Product Code | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-25 |
Decision Date | 2018-05-08 |
Summary: | summary |