510(k) K152098
- Device
- ODALYS Pedicle Screw System
- Applicant
- Kisco International
- 510(k) number
- K152098
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-17
- Date received
- 2015-07-28
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hiroko Ito
- Address
- 2 Pl. Berthe Morisot Saint-Priest FR 69800 69800
FDA Registration Numbers#
- 1221053
- 3009760038
- 3004638600
- 3008534770
- 3014763043
- 3006846753
- 3003935342
- 3004176895
- 3008749819
- 3004893332
- 3009732568
- 3009144915
- 3006356043
- 1527105
- 1833920
- 3040335671
- 9617297
- 1649518
- 3009051471
- 3009169996
- 3004635447
- 9610612
- 2032098
- 1225838
- 3010032903
- 2134947
- 3008583793
- 3010120339
- 2648623
- 3010440433
- 1222773
- 3016443334
- 3011277306
- 3016261131
- 3010097171
- 3009050824
- 3006217744
- 3003525643
- 3017528621
- 3010370500
- 3008102042
- 3015876273
- 3003761012
- 3009882675
- 1226544
- 3007887127
- 1000517406
- 2032112
- 3009973336
- 3009110133
- 3004638532
- 2183744
- 3009973505
- 3010120326
- 9617544
- 3006082533
- 3010370554
- 3015860552
- 3010120148
- 3005706667
- 3002808227
- 3014655115
- 3017435639
- 3003855635
- 3010178296
- 3010197239
- 3013548554
- 1828288
- 3010041499
- 3006849754
- 3010509633
- 3015967359
- 3010049501
- 3006460162
- 2032830
- 3015212339
- 3007125392
- 1531174
- 2031966
- 3008526708
Source Documents#
Other 510(k) Records For Product Code MNI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 |
Legacy Summary#
summary
FDA Review#
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