The following data is part of a premarket notification filed by Nexus Spine, Llc with the FDA for Stable-c Interbody System.
| Device ID | K181621 |
| 510k Number | K181621 |
| Device Name: | Stable-C Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Contact | Jared Crocker |
| Correspondent | Jared Crocker Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-20 |
| Decision Date | 2018-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6785230600 | K181621 | 000 |
| B6785230440 | K181621 | 000 |
| B6785230430 | K181621 | 000 |
| B6785230420 | K181621 | 000 |
| B6785230410 | K181621 | 000 |
| B6785230400 | K181621 | 000 |
| B6785230390 | K181621 | 000 |
| B6785230380 | K181621 | 000 |
| B6785230370 | K181621 | 000 |
| B6785230360 | K181621 | 000 |
| B6785230350 | K181621 | 000 |
| B6785230340 | K181621 | 000 |
| B6785230330 | K181621 | 000 |
| B6785230320 | K181621 | 000 |
| B6785230450 | K181621 | 000 |
| B6785230460 | K181621 | 000 |
| B6785230590 | K181621 | 000 |
| B6785230580 | K181621 | 000 |
| B6785230570 | K181621 | 000 |
| B6785230560 | K181621 | 000 |
| B6785230550 | K181621 | 000 |
| B6785230540 | K181621 | 000 |
| B6785230530 | K181621 | 000 |
| B6785230520 | K181621 | 000 |
| B6785230510 | K181621 | 000 |
| B6785230500 | K181621 | 000 |
| B6785230490 | K181621 | 000 |
| B6785230480 | K181621 | 000 |
| B6785230470 | K181621 | 000 |
| B6785230310 | K181621 | 000 |
| B6785230300 | K181621 | 000 |
| B6785230140 | K181621 | 000 |
| B6785230130 | K181621 | 000 |
| B6785230120 | K181621 | 000 |
| B6785230110 | K181621 | 000 |
| B6785230100 | K181621 | 000 |
| B6785230090 | K181621 | 000 |
| B6785230080 | K181621 | 000 |
| B6785230070 | K181621 | 000 |
| B6785230060 | K181621 | 000 |
| B6785230050 | K181621 | 000 |
| B6785230040 | K181621 | 000 |
| B6785230030 | K181621 | 000 |
| B6785230020 | K181621 | 000 |
| B6785230150 | K181621 | 000 |
| B6785230160 | K181621 | 000 |
| B6785230290 | K181621 | 000 |
| B6785230280 | K181621 | 000 |
| B6785230270 | K181621 | 000 |
| B6785230260 | K181621 | 000 |
| B6785230250 | K181621 | 000 |
| B6785230240 | K181621 | 000 |
| B6785230230 | K181621 | 000 |
| B6785230220 | K181621 | 000 |
| B6785230210 | K181621 | 000 |
| B6785230200 | K181621 | 000 |
| B6785230190 | K181621 | 000 |
| B6785230180 | K181621 | 000 |
| B6785230170 | K181621 | 000 |
| B6785230010 | K181621 | 000 |
| B6785230610 | K181621 | 000 |
| B6788230480 | K181621 | 000 |
| B6785233130 | K181621 | 000 |
| B6785233120 | K181621 | 000 |
| B6785233110 | K181621 | 000 |
| B6785233100 | K181621 | 000 |
| B6785233090 | K181621 | 000 |
| B6785233080 | K181621 | 000 |
| B6785233070 | K181621 | 000 |
| B6785233060 | K181621 | 000 |
| B6785233050 | K181621 | 000 |
| B6785231040 | K181621 | 000 |
| B6785231030 | K181621 | 000 |
| B6785231020 | K181621 | 000 |
| B6785231010 | K181621 | 000 |
| B6785233140 | K181621 | 000 |
| B6785233150 | K181621 | 000 |
| B6785233280 | K181621 | 000 |
| B6785233270 | K181621 | 000 |
| B6785233260 | K181621 | 000 |
| B6785233250 | K181621 | 000 |
| B6785233240 | K181621 | 000 |
| B6785233230 | K181621 | 000 |
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| B6785233170 | K181621 | 000 |
| B6785233160 | K181621 | 000 |
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| B6785230640 | K181621 | 000 |
| B6785230630 | K181621 | 000 |
| B6785230840 | K181621 | 000 |
| B6785230850 | K181621 | 000 |
| B6785230980 | K181621 | 000 |
| B6785230970 | K181621 | 000 |
| B6785230960 | K181621 | 000 |
| B6785230950 | K181621 | 000 |
| B6785230940 | K181621 | 000 |
| B6785230930 | K181621 | 000 |
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| B6785230910 | K181621 | 000 |
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| B6785230880 | K181621 | 000 |
| B6785230870 | K181621 | 000 |
| B6785230860 | K181621 | 000 |
| B6785230620 | K181621 | 000 |