510(k) K082032
- Device
- SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
- Applicant
- ABBOTT SPINE, INC.
- 510(k) number
- K082032
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-06
- Date received
- 2008-07-17
- 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 PADGETT
- Address
- 5301 Riata Park Ct. Bldg. F Austin TX US 78727 78727
FDA Registration Numbers#
- 3017780544
- 3009173317
- 3011390763
- 3014725904
- 3003541440
- 3005562917
- 8010099
- 3009973699
- 3021006165
- 3010041430
- 1000200989
- 3005083075
- 3022518322
- 3009959868
- 9617616
- 1530390
- 3006783837
- 3007887127
- 3015426608
- 3004142400
- 3000170817
- 1221763
- 3014937101
- 3010175289
- 3022159082
- 1319429
- 1528646
- 3013111980
- 3004788213
- 2531477
- 3017036472
- 3004153896
- 3013756169
- 3007738812
- 1526439
- 3011187779
- 3014273424
- 3013491327
- 3010032903
- 1043653
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3008534770
- 3012491394
- 3015487912
- 3005874553
- 1835831
- 3037407500
- 1828464
- 1833506
- 3007334927
- 3004774118
- 3010531060
- 3012428435
- 3007125392
- 9617544
- 3006984710
- 2028632
- 9681465
- 1835444
- 3014268622
- 3010863450
- 2530808
- 1000432246
- 3006356043
- 3015941638
- 3010143171
- 3043234953
- 3013548554
- 3015869493
- 3006404071
- 9615766
- 3001239363
- 3007539489
- 3005076207
- 1836357
- 3010462278
- 3011796723
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#
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FDA Review#
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