510(k) K091291
- Device
- XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
- Applicant
- STRYKER SPINE
- 510(k) number
- K091291
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-24
- Date received
- 2009-05-01
- 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
- CURTIS TRUESDALE
- Address
- 2 Pearl Ct. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 9617297
- 3007604895
- 1226544
- 3002806603
- 3007993775
- 3007485169
- 3006846753
- 3011221483
- 3010866843
- 1000493591
- 3009554293
- 3005819474
- 9615766
- 3006563559
- 3017780544
- 3015869121
- 3043543260
- 3010370880
- 3010646402
- 2531477
- 3013514648
- 3036756245
- 3034676720
- 3014387294
- 3013546462
- 1828288
- 3011556898
- 3015941638
- 3024999441
- 3009882462
- 3022518322
- 2133687
- 3008526708
- 3006217744
- 3016443334
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3016244279
- 3007279845
- 3010041993
- 1043214
- 3010120135
- 3008110533
- 3009169872
- 3010363503
- 3010665091
- 2032112
- 3017565094
- 1047843
- 3031240334
- 3014252644
- 3018780416
- 1526439
- 1527105
- 1221763
- 3004774118
- 3008102042
- 2029275
- 9681465
- 1531050
- 3010041430
- 3009504230
- 1424263
- 3008793310
- 3000170817
- 3007353762
- 3005562917
- 3016261131
- 3015383864
- 3003935342
- 3009173317
- 3008959459
- 3013111980
- 3012711663
- 3018210489
- 2032093
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 |
Legacy Summary#
summary
FDA Review#
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