510(k) K262712
- Device
- Duet™ Spinal Fixation System
- Applicant
- Duet Spine Holdings, LLC
- 510(k) number
- K262712
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-30
- Date received
- 2026-07-31
- 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
- N
Applicant Contact#
- Contact
- Jill Serbousek
- Address
- P.O. Box 420 Winona Lake IN US 46590 46590
FDA Registration Numbers#
- 3010123206
- 3003525643
- 1824199
- 9615128
- 3013055499
- 3010370500
- 3006563559
- 3015876273
- 3014763043
- 3008114965
- 3026311512
- 3001239363
- 3021945817
- 3006082533
- 1000432246
- 3014252644
- 3023138345
- 3009631939
- 3010120104
- 1000461041
- 3031261833
- 3009971621
- 1643817
- 3011181154
- 1529009
- 3007014520
- 3010120339
- 8043792
- 3014680795
- 3005061536
- 3010365473
- 1834331
- 3005677016
- 3009973505
- 2530808
- 3010329663
- 3012770122
- 3007345964
- 2183744
- 3014003062
- 3009540749
- 3016050940
- 1047843
- 3017155536
- 3006128100
- 1531174
- 3007993775
- 3010160527
- 9617616
- 3009973699
- 3009144915
- 3010128826
- 2133687
- 3005180920
- 1319429
- 3017036472
- 3010123256
- 3015443158
- 3018780416
- 3012428435
- 3004153896
- 2028632
- 3015869121
- 2031966
- 3009049161
- 3006846753
- 3008110533
- 3004788213
- 3010462278
- 3003855635
- 1424434
- 3009732568
- 3043543260
- 2648623
- 3006493760
- 3006217744
- 3003477135
- 1649518
- 2183449
- 1530390
Source Documents#
Other 510(k) Records For Product Code NKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261217 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | 2026-10-02 |
| K263062 | NOVIX Pedicle Screw System | Tdm Co., Ltd. | 2026-10-01 |
| K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | 2026-09-30 |
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026-09-27 |
| K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026-09-23 |
| 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 |