The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Contoured Synmesh Spacer.
| Device ID | K041389 |
| 510k Number | K041389 |
| Device Name: | SYNTHES CONTOURED SYNMESH SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SYNTHES SPINE 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Angela Mikroulis |
| Correspondent | Angela Mikroulis SYNTHES SPINE 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-25 |
| Decision Date | 2004-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814954910 | K041389 | 000 |
| H9814956350 | K041389 | 000 |
| H9814956370 | K041389 | 000 |
| H9814956380 | K041389 | 000 |
| H9814956410 | K041389 | 000 |
| H9814956420 | K041389 | 000 |
| H9814956440 | K041389 | 000 |
| H9814956450 | K041389 | 000 |
| H9814956470 | K041389 | 000 |
| H9814956480 | K041389 | 000 |
| H9814956340 | K041389 | 000 |