X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Inter
Spinal Vertebral Body Replacement Device
Medos International SARL
The following data is part of a premarket notification filed by Medos International Sarl with the FDA for X-mesh® Expandable Cage System, Ocelot® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, Bengal Stackable Cage System, Bengal System, Concorde® System, Concorde® Inline Lumbar Interbody System, Concorde® Curve Lumbar Inter.
Pre-market Notification Details
| Device ID | K173787 |
| 510k Number | K173787 |
| Device Name: | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Inter |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Sheree Geller |
| Correspondent | Sheree Geller DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MQP |
| Subsequent Product Code | EZX |
| Subsequent Product Code | MAX |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-06-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034051536 | K173787 | 000 |
| 10705034036533 | K173787 | 000 |
| 10705034036526 | K173787 | 000 |
| 10705034036519 | K173787 | 000 |
| 10705034036502 | K173787 | 000 |
| 10705034036496 | K173787 | 000 |
| 10705034036281 | K173787 | 000 |
| 10705034036274 | K173787 | 000 |
| 10705034035840 | K173787 | 000 |
| 10705034017921 | K173787 | 000 |
| 10705034017914 | K173787 | 000 |
| 10705034017884 | K173787 | 000 |
| 10705034036540 | K173787 | 000 |
| 10705034036557 | K173787 | 000 |
| 10705034036564 | K173787 | 000 |
| 10705034051475 | K173787 | 000 |
| 10705034051420 | K173787 | 000 |
| 10705034037028 | K173787 | 000 |
| 10705034036847 | K173787 | 000 |
| 10705034036830 | K173787 | 000 |
| 10705034036816 | K173787 | 000 |
| 10705034036731 | K173787 | 000 |
| 10705034036694 | K173787 | 000 |
| 10705034036601 | K173787 | 000 |
| 10705034036588 | K173787 | 000 |
| 10705034036571 | K173787 | 000 |
| 10705034017877 | K173787 | 000 |
Trademark Results [X-MESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-MESH 77841920 4056835 Live/Registered |
WALLNER EXPAC, INC. 2009-10-05 |
 X-MESH 77344762 3680602 Live/Registered |
DEPUY SYNTHES, INC. 2007-12-05 |
 X-MESH 74604419 2303090 Dead/Cancelled |
Dramex Corporation 1994-11-29 |
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