The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Loop Cage.
| Device ID | K121332 |
| 510k Number | K121332 |
| Device Name: | LOOP CAGE |
| 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 | 2012-05-03 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169398771 | K121332 | 000 |
| 00643169241756 | K121332 | 000 |
| 00643169241732 | K121332 | 000 |
| 00643169241725 | K121332 | 000 |
| 00643169241718 | K121332 | 000 |
| 00643169241688 | K121332 | 000 |
| 00643169241671 | K121332 | 000 |
| 00643169241664 | K121332 | 000 |
| 04250328214672 | K121332 | 000 |
| 04250328214375 | K121332 | 000 |
| 04250328214368 | K121332 | 000 |
| 04250328214351 | K121332 | 000 |
| 04250328203195 | K121332 | 000 |
| 04250328203188 | K121332 | 000 |
| 04250328203171 | K121332 | 000 |
| 04250328203164 | K121332 | 000 |
| 04250328203157 | K121332 | 000 |
| 04250328203133 | K121332 | 000 |
| 00643169241763 | K121332 | 000 |
| 00643169241770 | K121332 | 000 |
| 00643169241787 | K121332 | 000 |
| 00643169398764 | K121332 | 000 |
| 00643169398757 | K121332 | 000 |
| 00643169241961 | K121332 | 000 |
| 00643169241954 | K121332 | 000 |
| 00643169241947 | K121332 | 000 |
| 00643169241930 | K121332 | 000 |
| 00643169241923 | K121332 | 000 |
| 00643169241916 | K121332 | 000 |
| 00643169241909 | K121332 | 000 |
| 00643169241893 | K121332 | 000 |
| 00643169241886 | K121332 | 000 |
| 00643169241879 | K121332 | 000 |
| 00643169241855 | K121332 | 000 |
| 00643169241848 | K121332 | 000 |
| 00643169241817 | K121332 | 000 |
| 00643169241800 | K121332 | 000 |
| 00643169241794 | K121332 | 000 |
| 04250328203126 | K121332 | 000 |