The following data is part of a premarket notification filed by 4web, Inc. with the FDA for 4web Spinal Implant Products.
Device ID | K142112 |
510k Number | K142112 |
Device Name: | 4WEB SPINAL IMPLANT PRODUCTS |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | 4WEB, INC. 11821 BRAMBLE COVE DRIVE Ft.myers, FL 33905 |
Contact | Rich Jansen |
Correspondent | Rich Jansen 4WEB, INC. 11821 BRAMBLE COVE DRIVE Ft.myers, FL 33905 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-04 |
Decision Date | 2014-09-23 |
Summary: | summary |