The following data is part of a premarket notification filed by Surgtech Inc with the FDA for Surgtech Interbody System.
| Device ID | K152200 |
| 510k Number | K152200 |
| Device Name: | SurgTech Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SURGTECH INC 24600 CENTER RIDGE ROAD, SUITE 195 Westlake, OH 44145 |
| Contact | Xuegong Yu |
| Correspondent | Karen E. Warden BACKROADS CONSULTING INC. PO BOX 566 Chesterland, OH 44026 -0566 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-06 |
| Decision Date | 2016-03-25 |
| Summary: | summary |