510(k) K113361
- Device
- SECURIS SPINAL FIXATION
- Applicant
- CUMTOM SPINE
- 510(k) number
- K113361
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-03
- Date received
- 2011-11-14
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID BRUMFIELD
- Address
- 1140 Parsippany Blvd. Suite 201 Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3014273424
- 3009962553
- 3006563559
- 3014763043
- 3013756169
- 3039169546
- 3013194153
- 3010365473
- 3009957608
- 3008110533
- 3010041993
- 3014938863
- 3010047454
- 3009049161
- 3012381896
- 1047843
- 9615014
- 1043653
- 3009540749
- 3008868758
- 2028632
- 3014725904
- 3006378738
- 3010097171
- 3011301313
- 2031966
- 3013111980
- 3007887127
- 3010120148
- 3004024955
- 3020282716
- 3000170817
- 1220477
- 3009888740
- 3003761012
- 3008583793
- 3017155536
- 9611274
- 3018210489
- 3010160527
- 3017528621
- 3016261131
- 3005031160
- 3009417901
- 9617616
- 3015831087
- 3012120772
- 3027807601
- 2249608
- 3007700286
- 2135156
- 3013422236
- 3015967359
- 1527105
- 1835831
- 1935627
- 1649379
- 2134285
- 1828464
- 9611610
- 1834331
- 3009941480
- 3009217531
- 3006082533
- 1030489
- 1424263
- 3008102042
- 3015941638
- 3009051471
- 3011874600
- 3017036472
- 3007766698
- 8010099
- 9611390
- 3038505140
- 3030412764
- 2032098
- 3005827567
- 1529009
- 1833920
Source Documents#
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System | Globus Medical, Inc. | 2026-05-07 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-04-03 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | 2026-02-24 |
| K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | 2026-02-23 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-01-07 |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
Legacy Summary#
summary
FDA Review#
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