510(k) K163096
- Device
- GPC BRAND Posterior, Non Cervical Pedicle Screw Spinal System
- Applicant
- GPC MEDICAL LIMITED
- 510(k) number
- K163096
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-31
- Date received
- 2016-11-04
- 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
- VIKAS NARANG
- Address
- Gpc Sq., M-Block, Dda, Lsc, Vikas Puri New Delhi IN 110018 110018
FDA Registration Numbers#
- 3007700286
- 1221053
- 3004638600
- 3008534770
- 3014763043
- 3006846753
- 3003935342
- 3004176895
- 8010099
- 1531050
- 3014257776
- 3004893332
- 3009732568
- 3009144915
- 3006356043
- 1527105
- 1833920
- 3015426608
- 3010303097
- 3031261833
- 3040335671
- 9617297
- 3010646402
- 3005641619
- 1649518
- 3009051471
- 3004635447
- 9610612
- 2032098
- 1225838
- 3022472578
- 3010032903
- 9617616
- 2134947
- 3008583793
- 3010120339
- 2648623
- 3010440433
- 3013546462
- 1222773
- 3017780544
- 3016443334
- 3011277306
- 3016261131
- 3010097171
- 3009050824
- 3006217744
- 3003525643
- 3017528621
- 3010370500
- 3008102042
- 3015876273
- 3003761012
- 3009882675
- 1226544
- 3007887127
- 1000517406
- 2032112
- 3009973336
- 3009110133
- 3004638532
- 2183744
- 3013846070
- 3009973505
- 3010120326
- 9617544
- 3010665091
- 3011656326
- 3006082533
- 3010370554
- 3010120148
- 3007539489
- 3005706667
- 3002808227
- 3014655115
- 3017435639
- 3003855635
- 2244478
- 3010178296
Source Documents#
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | 2026-07-24 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026-07-14 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-07-01 |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| 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 |
Legacy Summary#
summary
FDA Review#
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