510(k) K151648
- Device
- Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
- Applicant
- Altus Partners, LLC
- 510(k) number
- K151648
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-16
- Date received
- 2015-06-18
- 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
- Claudia Hill
- Address
- 5129 W. Chester Pike Newtown Square PA US 19073 19073
FDA Registration Numbers#
- 3010057495
- 3010370500
- 3010303097
- 3009957608
- 3011500362
- 3010646402
- 9615766
- 3014268622
- 3006791286
- 1528646
- 1835831
- 1834379
- 3015179588
- 3025603301
- 3000203391
- 3015426608
- 3005641619
- 3011181154
- 3015383864
- 3017565094
- 3007887127
- 3012764194
- 3006082533
- 3007353762
- 3009882675
- 3013011598
- 3010120135
- 2530808
- 3029933740
- 3012994232
- 3012491394
- 3005823819
- 9611813
- 3011964577
- 3019356409
- 9612277
- 3018210489
- 3040335671
- 3009973505
- 3009049161
- 8010099
- 3022472578
- 3007345964
- 1424263
- 9616944
- 3008102042
- 3009988302
- 3021945817
- 9615128
- 3014252644
- 3004774118
- 2648623
- 3036756245
- 1530390
- 3016438694
- 1643817
- 3031240334
- 3008285983
- 3016244279
- 1047843
- 3004941535
- 1319660
- 3006404071
- 3010041993
- 3014273424
- 3004024955
- 3002808227
- 3013546462
- 3009998573
- 3006639944
- 3004788213
- 1057425
- 3009165919
- 1220477
- 2032112
- 9617544
- 1224360
- 2032098
- 3013055499
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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