510(k) K170045

Device: Swedge™ Pedicle Screw Fixation System
Applicant: Spinal Resources, Inc.
510(k) number: K170045
Product code: NKB
Decision: Substantially Equivalent (SESE)
Decision date: 2017-06-26
Date received: 2017-01-05
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

Related Records

Applicant Contact

Contact: Bernard Bedor
Address: 5450 Nw. 33rd Ave. Unit 103 Fort Lauderdale FL US 33309 33309

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

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
B515PSST6550	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515RMCC5570	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST5540	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST6535	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST6545	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST6540	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST5545	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST6555	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515PSST5535	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-05-09
B515LC050	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2024-01-30
B515LC030	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2020-06-08
B515LC040	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2020-06-08
B51521250	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521510	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521270	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521370	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521300	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521280	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521290	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521380	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521420	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B5152139010	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B5152140020	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521350	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B515SRI10010	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B5152126010	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B515SRI10040	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521240	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B51521310	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14
B5152126020	Swedge Pedicle Screw Fixation System	SPINAL RESOURCES, INC.	2018-03-14

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

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