The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Trabecular Metal (tm) Fusion Device.
| Device ID | K111119 |
| 510k Number | K111119 |
| Device Name: | TRABECULAR METAL (TM) FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ZIMMER SPINE, INC 12708 RIATA VISTA CIRCLE SUITE B-100 Austin, TX 78727 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ZIMMER SPINE, INC 12708 RIATA VISTA CIRCLE SUITE B-100 Austin, TX 78727 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024313613 | K111119 | 000 |
| 00889024316942 | K111119 | 000 |
| 00889024316874 | K111119 | 000 |
| 00889024316867 | K111119 | 000 |
| 00889024316850 | K111119 | 000 |
| 00889024316782 | K111119 | 000 |
| 00889024316775 | K111119 | 000 |
| 00889024316768 | K111119 | 000 |
| 00889024316690 | K111119 | 000 |
| 00889024316416 | K111119 | 000 |
| 00889024316409 | K111119 | 000 |
| 00889024316331 | K111119 | 000 |
| 00889024316324 | K111119 | 000 |
| 00889024316317 | K111119 | 000 |
| 00889024316249 | K111119 | 000 |
| 00889024316232 | K111119 | 000 |
| 00889024316225 | K111119 | 000 |
| 00889024316959 | K111119 | 000 |
| 00889024313088 | K111119 | 000 |
| 00889024313606 | K111119 | 000 |
| 00889024313538 | K111119 | 000 |
| 00889024313521 | K111119 | 000 |
| 00889024313514 | K111119 | 000 |
| 00889024313446 | K111119 | 000 |
| 00889024313439 | K111119 | 000 |
| 00889024313422 | K111119 | 000 |
| 00889024313354 | K111119 | 000 |
| 00889024313347 | K111119 | 000 |
| 00889024313330 | K111119 | 000 |
| 00889024313262 | K111119 | 000 |
| 00889024313255 | K111119 | 000 |
| 00889024313248 | K111119 | 000 |
| 00889024313170 | K111119 | 000 |
| 00889024313163 | K111119 | 000 |
| 00889024313156 | K111119 | 000 |
| 00889024316157 | K111119 | 000 |