510(k) K143222
- Device
- FIREFLY Pedicle Screw Navigation Guide
- Applicant
- Mighty Oak Medical Inc
- 510(k) number
- K143222
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-11
- Date received
- 2014-11-10
- 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
- Heidi Frey
- Address
- 777 E Girard Ave. Suite 150 Englewood CO US 80113 80113
FDA Registration Numbers#
- 3003935342
- 1223434
- 3011221483
- 1722511
- 3010160527
- 3010606097
- 3009882675
- 1835572
- 3008455034
- 8020776
- 3006017180
- 3009173317
- 3030412764
- 3023265483
- 3011577940
- 3007993775
- 3015941638
- 3007675554
- 3006378738
- 3002808227
- 3005596514
- 3010123206
- 3010370500
- 3008992889
- 3006460162
- 3003639920
- 3004111573
- 3004719693
- 3013055499
- 3014763043
- 2183449
- 3010866843
- 3013011598
- 3012329926
- 3010041430
- 3011874600
- 3015831087
- 3013548554
- 3006563559
- 3002976036
- 9616944
- 2134470
- 3009165919
- 9616062
- 1720929
- 1526534
- 2648666
- 1000493591
- 9611813
- 3007887127
- 3019837678
- 1828288
- 3012863589
- 9617297
- 3009050824
- 1834331
- 1056553
- 3009888740
- 3010531060
- 1000200989
- 9681642
- 3014725904
- 3008110533
- 3011796723
- 3009106092
- 3011277306
- 3004638532
- 1225838
- 3008812560
- 3009110133
- 3008850074
- 1935627
- 3004499989
- 3008285983
- 3009959868
- 3016438694
- 3033509898
- 3010370880
- 3004635447
- 2133687
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 |
| 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 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 |
Legacy Summary#
summary
FDA Review#
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