EXACTECH GPS
Neurological Stereotaxic Instrument
BLUE ORTHO
The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactech Gps.
Pre-market Notification Details
| Device ID | K152764 |
| 510k Number | K152764 |
| Device Name: | EXACTECH GPS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BLUE ORTHO 5 AVENUE DU GRAND SABLON La Tronche, FR 38700 |
| Contact | Anthony Boyer |
| Correspondent | Anthony Boyer BLUE ORTHO 5 AVENUE DU GRAND SABLON La Tronche, FR 38700 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2016-07-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862604897 | K152764 | 000 |
| 10885862604804 | K152764 | 000 |
| 10885862604798 | K152764 | 000 |
| 10885862604781 | K152764 | 000 |
Trademark Results [EXACTECH GPS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXACTECH GPS 77818852 4053501 Live/Registered |
Exactech, Inc. 2009-09-02 |
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