ORTHOMESH
Plate, Fixation, Bone
SYNTHES (USA)
The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Orthomesh.
Pre-market Notification Details
| Device ID | K073115 |
| 510k Number | K073115 |
| Device Name: | ORTHOMESH |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-07-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67980400602S0 | K073115 | 000 |
| H67980360502S0 | K073115 | 000 |
| H67985171297S0 | K073115 | 000 |
| H67985171197S0 | K073115 | 000 |
Trademark Results [ORTHOMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOMESH 77717635 3759211 Live/Registered |
DEPUY SYNTHES, INC. 2009-04-20 |
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