The following data is part of a premarket notification filed by Captiva Spine with the FDA for Captiva Spine Smartlox Cervical Plate System.
| Device ID | K141332 |
| 510k Number | K141332 |
| Device Name: | Captiva Spine SmartLOX Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CAPTIVA SPINE 967 ALTERNATE A1A #1 Jupiter, FL 33477 |
| Contact | Tamala J Wampler |
| Correspondent | Richard Jansen Silver Spine Consulting 13540 Guide Ave Apple Valley, MN 55124 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2015-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739131064012 | K141332 | 000 |
| M739CP300380 | K141332 | 000 |
| M739CP300400 | K141332 | 000 |
| M739CP300420 | K141332 | 000 |
| M739CP300440 | K141332 | 000 |
| M739CP300460 | K141332 | 000 |
| M739CP300480 | K141332 | 000 |
| M739CP300500 | K141332 | 000 |
| M739CP300520 | K141332 | 000 |
| M739CP300550 | K141332 | 000 |
| M739CP300580 | K141332 | 000 |
| M739CP300610 | K141332 | 000 |
| M739CP300640 | K141332 | 000 |
| M739CP300670 | K141332 | 000 |
| M739CP300360 | K141332 | 000 |
| M739CP300340 | K141332 | 000 |
| M739CP300320 | K141332 | 000 |
| M739131064014 | K141332 | 000 |
| M739131064016 | K141332 | 000 |
| M739131064018 | K141332 | 000 |
| M739131164012 | K141332 | 000 |
| M739131164014 | K141332 | 000 |
| M739131164016 | K141332 | 000 |
| M739131164018 | K141332 | 000 |
| M739CP300200 | K141332 | 000 |
| M739CP300220 | K141332 | 000 |
| M739CP300240 | K141332 | 000 |
| M739CP300260 | K141332 | 000 |
| M739CP300280 | K141332 | 000 |
| M739CP300300 | K141332 | 000 |
| M739CP300700 | K141332 | 000 |
| M739CP300740 | K141332 | 000 |
| M739CP300780 | K141332 | 000 |
| M739CP400120 | K141332 | 000 |
| M739CP400130 | K141332 | 000 |
| M739CP400140 | K141332 | 000 |
| M739CP400150 | K141332 | 000 |
| M739CP400160 | K141332 | 000 |
| M739CP400170 | K141332 | 000 |
| M739CP400180 | K141332 | 000 |
| M739CP501000 | K141332 | 000 |
| M739CP501200 | K141332 | 000 |
| M739CP501400 | K141332 | 000 |
| M739CP501800 | K141332 | 000 |
| M739CP501900 | K141332 | 000 |
| M739CP502000 | K141332 | 000 |
| M739CP400110 | K141332 | 000 |
| M739CP400010 | K141332 | 000 |
| M7393030010000 | K141332 | 000 |
| M739CP300820 | K141332 | 000 |
| M739CP300860 | K141332 | 000 |
| M739CP300900 | K141332 | 000 |
| M739CP304700 | K141332 | 000 |
| M7391334000110 | K141332 | 000 |
| M7391334000120 | K141332 | 000 |
| M7391334000130 | K141332 | 000 |
| M7391334000140 | K141332 | 000 |
| M7391334000150 | K141332 | 000 |
| M7391334000160 | K141332 | 000 |
| M7391334000170 | K141332 | 000 |
| M7391334000180 | K141332 | 000 |
| M7391349901040 | K141332 | 000 |
| M739CP502100 | K141332 | 000 |