The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Fuse Plif Cafe.
| Device ID | K100945 |
| 510k Number | K100945 |
| Device Name: | FUSE PLIF CAFE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ADVANCED MEDICAL TECHNOLOGIES AG 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ADVANCED MEDICAL TECHNOLOGIES AG 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-06 |
| Decision Date | 2011-02-09 |
| Summary: | summary |