510(k) K100765
- Device
- FIXPINE II SYSTEM
- Applicant
- DIO MEDICAL CO., LTD.
- 510(k) number
- K100765
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-19
- Date received
- 2010-03-17
- 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
- JOYCE BANG
- Address
- 13340 E Firestone Blvd. Suite J Santa Fe Springs CA US 90670 90670
FDA Registration Numbers#
- 3008583793
- 3006791286
- 3011577940
- 3000203391
- 2133687
- 3009941480
- 3004464325
- 3013055499
- 2532027
- 3007125392
- 3010097171
- 3010032903
- 3010120104
- 3004638532
- 3010370554
- 3003639920
- 3009887475
- 1225838
- 3010120148
- 1423662
- 2133928
- 3009882675
- 3009509485
- 3006128100
- 3009106092
- 1319660
- 9681465
- 3009973699
- 3037407500
- 2031093
- 3008455034
- 3005677016
- 9611813
- 9615021
- 3014725904
- 1417485
- 3010120339
- 3005180920
- 3005031160
- 3004788213
- 9611390
- 3009962553
- 3009732568
- 9616944
- 3009165919
- 8010944
- 3010057495
- 1835831
- 3011796723
- 3009417901
- 3008850074
- 3015941638
- 3010440433
- 2648666
- 3017528621
- 3018094310
- 3008198024
- 1527105
- 3010531060
- 3010123256
- 2134285
- 3023138345
- 1319429
- 1835296
- 3010178296
- 3015869493
- 3016438694
- 3004941535
- 1000493591
- 2134470
- 2531477
- 2183449
- 1824199
- 3005596514
- 3006404019
- 3003855635
- 3012491394
- 3004717358
- 1030489
- 1722511
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 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
Legacy Summary#
summary
FDA Review#
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