The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Fuse Cage.
| Device ID | K121288 |
| 510k Number | K121288 |
| Device Name: | FUSE CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ADVANCED MEDICAL TECHNOLOGIES AG KASTELER STRASSE 11 Nonnweiler-braunshausen, DE 66620 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ADVANCED MEDICAL TECHNOLOGIES AG KASTELER STRASSE 11 Nonnweiler-braunshausen, DE 66620 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169245723 | K121288 | 000 |
| 04250328208015 | K121288 | 000 |
| 04250328208855 | K121288 | 000 |
| 04250328210414 | K121288 | 000 |
| 04250328214634 | K121288 | 000 |
| 04250328214641 | K121288 | 000 |
| 00643169245464 | K121288 | 000 |
| 00643169245471 | K121288 | 000 |
| 00643169245488 | K121288 | 000 |
| 04250328208008 | K121288 | 000 |
| 04250328207988 | K121288 | 000 |
| 04250328207841 | K121288 | 000 |
| 04250328207889 | K121288 | 000 |
| 04250328207896 | K121288 | 000 |
| 04250328207919 | K121288 | 000 |
| 04250328207926 | K121288 | 000 |
| 04250328207940 | K121288 | 000 |
| 04250328207957 | K121288 | 000 |
| 04250328207971 | K121288 | 000 |
| 00643169245495 | K121288 | 000 |
| 00643169245501 | K121288 | 000 |
| 00643169245617 | K121288 | 000 |
| 00643169245624 | K121288 | 000 |
| 00643169245631 | K121288 | 000 |
| 00643169245648 | K121288 | 000 |
| 00643169245655 | K121288 | 000 |
| 00643169245662 | K121288 | 000 |
| 00643169245693 | K121288 | 000 |
| 00643169245716 | K121288 | 000 |
| 00643169245600 | K121288 | 000 |
| 00643169245594 | K121288 | 000 |
| 00643169245518 | K121288 | 000 |
| 00643169245525 | K121288 | 000 |
| 00643169245532 | K121288 | 000 |
| 00643169245549 | K121288 | 000 |
| 00643169245556 | K121288 | 000 |
| 00643169245563 | K121288 | 000 |
| 00643169245570 | K121288 | 000 |
| 00643169245587 | K121288 | 000 |
| 04250328207810 | K121288 | 000 |