510(k) K193472
- Device
- OrthoCircle Spine Pedicle Screw System
- Applicant
- OrthoCircle Spine
- 510(k) number
- K193472
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-13
- Date received
- 2019-12-16
- 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
- Jack Mathews
- Address
- 15 E. Montgomery Crossroads Suite 3 Savannah GA US 31406 31406
FDA Registration Numbers#
- 1000493591
- 3009380063
- 3007922509
- 9617544
- 2029275
- 1000432246
- 9611274
- 3010057495
- 3012447612
- 2648623
- 1835831
- 3015443158
- 3004635447
- 3010123256
- 3004638600
- 3008285983
- 1528646
- 3031261833
- 2032098
- 3009998573
- 3003387384
- 3040335671
- 3010866843
- 1424434
- 3004049923
- 8020776
- 3005819474
- 9611827
- 3006493760
- 3043543260
- 3009540749
- 3006404071
- 3011656326
- 3009417901
- 3015179588
- 1056553
- 3011795235
- 3023138345
- 3007345964
- 3022159082
- 3010440433
- 3012381896
- 3014387294
- 3011390763
- 1833824
- 1000200989
- 3013548554
- 3012770122
- 3010120339
- 3010041430
- 3021948057
- 3009380093
- 1045254
- 3029933740
- 3009882462
- 3009504230
- 3006082533
- 3005874553
- 2531477
- 3021945817
- 8010944
- 3011187779
- 2183744
- 2530808
- 3002806603
- 3013514648
- 1423662
- 3008102042
- 3003541440
- 3007334927
- 3010370554
- 3003526896
- 3011170410
- 2134947
- 3013055499
- 3009973505
- 3015399803
- 3006356043
- 3010531060
Source Documents#
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-09-17 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | 2026-09-14 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-09-04 |
| 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 |
Legacy Summary#
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FDA Review#
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