FIXATE TISSUE BAND
Stimulator, Spinal-cord, Implanted (pain Relief)
ANULEX TECHNOLOGIES, INC
The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Fixate Tissue Band.
Pre-market Notification Details
| Device ID | K113805 |
| 510k Number | K113805 |
| Device Name: | FIXATE TISSUE BAND |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-02-23 |
| Summary: | summary |
Trademark Results [FIXATE TISSUE BAND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIXATE TISSUE BAND 85332335 4247597 Live/Registered |
BOSTON SCIENTIFIC NEUROMODULATION CORPOR 2011-05-27 |
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