The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Synmesh.
| Device ID | K983766 |
| 510k Number | K983766 |
| Device Name: | SYNTHES SYNMESH |
| Classification | Mesh, Surgical, Metal |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | James Mccracken |
| Correspondent | James Mccracken SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1998-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814954690 | K983766 | 000 |
| H9814954790 | K983766 | 000 |
| H9814954780 | K983766 | 000 |
| H9814954770 | K983766 | 000 |
| H9814954760 | K983766 | 000 |
| H9814954750 | K983766 | 000 |
| H9814954740 | K983766 | 000 |
| H9814954730 | K983766 | 000 |
| H9814954720 | K983766 | 000 |
| H9814954710 | K983766 | 000 |
| H9814954550 | K983766 | 000 |
| H9814954510 | K983766 | 000 |
| H9814954460 | K983766 | 000 |
| H9814954450 | K983766 | 000 |
| H9814954440 | K983766 | 000 |
| H9814954430 | K983766 | 000 |
| H9814954420 | K983766 | 000 |
| H9814954810 | K983766 | 000 |
| H9814954820 | K983766 | 000 |
| H9814954680 | K983766 | 000 |
| H9814954670 | K983766 | 000 |
| H9814954660 | K983766 | 000 |
| H9814954650 | K983766 | 000 |
| H9814954640 | K983766 | 000 |
| H9814954630 | K983766 | 000 |
| H9814954620 | K983766 | 000 |
| H9814954610 | K983766 | 000 |
| H9814954900 | K983766 | 000 |
| H9814954890 | K983766 | 000 |
| H9814954880 | K983766 | 000 |
| H9814954870 | K983766 | 000 |
| H9814954860 | K983766 | 000 |
| H9814954850 | K983766 | 000 |
| H9814954840 | K983766 | 000 |
| H9814954830 | K983766 | 000 |
| H9814954410 | K983766 | 000 |