The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Shurfit 2c Lumbar Interbody Fusion System.
Device ID | K171657 |
510k Number | K171657 |
Device Name: | ShurFit 2C Lumbar Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
Contact | Michael C. Dawson |
Correspondent | Michael C. Dawson Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-05 |
Decision Date | 2017-08-11 |
Summary: | summary |