510(k) K130073
- Device
- MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
- Applicant
- MIKRON MAKINA SANAYI VE TICARET LTD STI
- 510(k) number
- K130073
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-16
- Date received
- 2013-01-11
- 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
- OMAR DIKER
- Address
- 80 Leicester Way Chesapeake City MD US 21915 21915
FDA Registration Numbers#
- 3014273424
- 3009962553
- 3006563559
- 3014763043
- 3010365473
- 3008110533
- 3010041993
- 3010047454
- 3009049161
- 3012381896
- 2032521
- 1043653
- 3008868758
- 2028632
- 3014725904
- 3006378738
- 3010097171
- 2031966
- 3007887127
- 3010120148
- 3004024955
- 3020282716
- 3000170817
- 1220477
- 3009888740
- 3003761012
- 3008583793
- 9611274
- 3018210489
- 3010160527
- 3017528621
- 3016261131
- 3005031160
- 3006272282
- 3009417901
- 3015831087
- 3012120772
- 1417485
- 2135156
- 3015967359
- 1527105
- 1835831
- 3009169996
- 1935627
- 1649379
- 2134285
- 1828464
- 1834331
- 3009941480
- 3006082533
- 1030489
- 3009217531
- 1424263
- 3008102042
- 3015941638
- 9614841
- 3009051471
- 3011874600
- 3015219237
- 3017036472
- 9611390
- 3030412764
- 2032098
- 1529009
- 1833920
- 3004464325
- 3010440433
- 3009106092
- 3010057495
- 3004941535
- 3001239363
- 3007675554
- 3009468807
- 3010120135
- 1224360
- 3012329926
- 3002807112
- 3011489618
- 1319660
- 3007353762
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 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
Legacy Summary#
summary
FDA Review#
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