Opti-Toe
Pin, Fixation, Smooth
Graham Medical Technologies, L.L.C. (d.b.a.GraMedica)
The following data is part of a premarket notification filed by Graham Medical Technologies, L.l.c. (d.b.a.gramedica) with the FDA for Opti-toe.
Pre-market Notification Details
| Device ID | K142478 |
| 510k Number | K142478 |
| Device Name: | Opti-Toe |
| Classification | Pin, Fixation, Smooth |
| Applicant | Graham Medical Technologies, L.L.C. (d.b.a.GraMedica) 7200 N IH 35 Building #1 Macomb, MI 48042 |
| Contact | Michael Graham |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-05-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M621OTSS0 | K142478 | 000 |
| M621OTSA0 | K142478 | 000 |
Trademark Results [Opti-Toe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTI-TOE 85513843 4827281 Live/Registered |
Graham, Michael 2012-01-11 |
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