The following data is part of a premarket notification filed by Medical Designs Llc with the FDA for Sp-link™ System.
Device ID | K182352 |
510k Number | K182352 |
Device Name: | SP-LINK™ System |
Classification | Spinous Process Plate |
Applicant | Medical Designs LLC 6709 S. Minnesota Ave, Suite 204 Sioux Falls, SD 57108 |
Contact | Kristi Vondra |
Correspondent | Kristi Vondra Medical Designs LLC 6709 S. Minnesota Ave, Suite 204 Sioux Falls, SD 57108 |
Product Code | PEK |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-29 |
Decision Date | 2018-11-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SP-LINK 88833410 not registered Live/Pending |
Asfora IP, LLC 2020-03-13 |
SP-LINK 86922890 not registered Live/Pending |
Asfora IP, LLC 2016-02-29 |
SP-LINK 85839585 not registered Dead/Abandoned |
VibraNova Corporation 2013-02-04 |
SP-LINK 77781646 not registered Dead/Abandoned |
VibraNova Corporation 2009-07-15 |