The following data is part of a premarket notification filed by 4web,inc. with the FDA for Plif Sts, Tlif Sts, Olif Sts (spinal Truss System).
| Device ID | K143258 |
| 510k Number | K143258 |
| Device Name: | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | 4WEB,INC. 6170 RESEARCH RD., SUITE 219 Frisco, TX 75033 |
| Contact | Jessee Hunt |
| Correspondent | Rich Jansen SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-04-09 |
| Summary: | summary |