510(k) K232719
- Device
- ProMIS Extension Rod System
- Applicant
- Premia Spine, Ltd.
- 510(k) number
- K232719
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-21
- Date received
- 2023-09-05
- 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
- Dorit Winitz
- Address
- 7 Giborey Israel St. Ramat Poleg, Netanya IL 4250407 4250407
FDA Registration Numbers#
- 1935627
- 3007728266
- 3039169546
- 3009509485
- 3017565094
- 3008812560
- 3004049923
- 3014003062
- 1000493591
- 3007993775
- 3009882462
- 3005739886
- 3016244279
- 3004024955
- 3010509633
- 3010365473
- 3010143171
- 1835572
- 3005180920
- 1424434
- 3016438694
- 3011556898
- 3015941638
- 3012764194
- 3013034344
- 3023138345
- 3005819474
- 3020282716
- 3010663372
- 3010440433
- 3007922509
- 1223434
- 3007604895
- 3012711663
- 9611827
- 3010120135
- 3008959459
- 3008868758
- 3014252644
- 1828288
- 3026311512
- 3009165919
- 1834331
- 3007485169
- 3010041499
- 1057425
- 3043543260
- 3043620689
- 3010175289
- 3010370880
- 3005677016
- 2133928
- 3016084569
- 1824199
- 3009962553
- 3013846070
- 3008455034
- 3013111980
- 3017780544
- 3016496998
- 3008114965
- 3000170817
- 1649518
- 3008534770
- 3010009693
- 3015426608
- 3012447612
- 3012120772
- 3005360851
- 2183744
- 2648623
- 3009417901
- 9611813
- 3005874553
- 8010944
- 2648666
- 3006984710
- 3014257776
- 3010531069
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 |
| K262712 | Duet™ Spinal Fixation System | Duet Spine Holdings, LLC | 2026-09-30 |
| 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 |