510(k) K041030
- Device
- MODIFICATION TO CD HORIZON SPINAL SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K041030
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-06-30
- Date received
- 2004-04-21
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3009051471
- 3004499989
- 3010197239
- 1526534
- 3010197224
- 9681465
- 3010120339
- 2183449
- 9611390
- 2032093
- 3004635447
- 2029005
- 2532027
- 3008114965
- 9610726
- 3010160527
- 3004941535
- 3010866843
- 3017528621
- 9617297
- 2530808
- 3009468807
- 3019837678
- 3011181154
- 3013011598
- 1828288
- 3010123206
- 3009882462
- 3009144915
- 3004142400
- 3023852420
- 3010120148
- 1030489
- 3009971621
- 3010041993
- 3010365473
- 1319660
- 3009173317
- 3010326971
- 3008572623
- 3009887475
- 3006563559
- 3010120104
- 3005325790
- 3023138345
- 3009631939
- 3006846753
- 3009959868
- 1043653
- 1935627
- 3010162973
- 1530530
- 3015860552
- 1834331
- 3006356043
- 3036756245
- 3010057495
- 3002807561
- 1531174
- 3008110533
- 3010462278
- 1528646
- 2133928
- 3005083075
- 3000270450
- 3008583793
- 2029275
- 1835444
- 1526439
- 3005497913
- 3009973699
- 3002807112
- 3006404019
- 2032098
- 2183744
- 3008455034
- 1045254
- 3011390763
- 8010944
- 1828464
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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