510(k) K181554
- Device
- Stowe Pedicle Screw System
- Applicant
- Black Box Medical
- 510(k) number
- K181554
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-27
- Date received
- 2018-06-13
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Todd Stanaford
- Address
- 4516 E. County Rd. 45 Midland TX US 79705 79705
FDA Registration Numbers#
- 3010097171
- 3001239363
- 1424263
- 1000577893
- 3040335671
- 3011577940
- 3010440433
- 3007014520
- 1000493591
- 3022518322
- 3010178296
- 3006513362
- 3002808227
- 3026311512
- 3016261131
- 3013546462
- 3006563559
- 3008102042
- 2532027
- 3009144915
- 1833920
- 3010057495
- 1319660
- 1835296
- 3011187779
- 3009217531
- 3007700286
- 3007997036
- 8020776
- 3002976036
- 1835572
- 3009509485
- 3005819474
- 1000517406
- 3009887475
- 3007353762
- 3009732568
- 3009051471
- 3009504230
- 3010049501
- 3009888740
- 1531174
- 3010646402
- 3009165919
- 3010462278
- 3011015572
- 3008455034
- 1223434
- 3006639944
- 3008110533
- 1720929
- 3010329663
- 3010120339
- 3017435639
- 9611813
- 3010175289
- 3010663372
- 1828288
- 3015487912
- 3007766698
- 3008526708
- 2648623
- 3009988302
- 8043792
- 1226544
- 9612277
- 3002806603
- 3009957608
- 3005497913
- 3009106092
- 3009381600
- 1224360
- 3012131184
- 3015399803
- 3004464325
- 3003639920
- 3010370554
- 3010120135
- 3031240334
Source Documents#
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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