510(k) K132788
- Device
- MYSPINE PEDICLE SCREW PLACEMENT GUIDES
- Applicant
- MEDACTA INTERNATIONAL
- 510(k) number
- K132788
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-23
- Date received
- 2013-09-06
- 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
- ADAM GROSS
- Address
- 4725 Calle Quetzal Unit B Camarillo CA US 93012 93012
FDA Registration Numbers#
- 2183449
- 3012491394
- 2183946
- 3009973699
- 2531195
- 3009760038
- 3012120772
- 1834379
- 9612277
- 1526534
- 3009971621
- 1030489
- 3004464325
- 3008868758
- 3010531060
- 3003541440
- 3010120104
- 3010120148
- 3016050940
- 1220477
- 1835444
- 1417485
- 3004111573
- 3015941638
- 3008285983
- 3012447612
- 3008992889
- 3011556898
- 1828288
- 2648666
- 3015869121
- 3005977257
- 3010197224
- 3010287685
- 1450662
- 3006404071
- 3019837678
- 3009144915
- 3003639920
- 9610612
- 1649379
- 3034676720
- 3019767615
- 3010047454
- 2031966
- 3002976036
- 3004635447
- 3013011598
- 1531174
- 3010120326
- 3004788213
- 3010041499
- 3014763043
- 3008583793
- 1824199
- 3009149199
- 1424263
- 3013548554
- 3010123206
- 1834331
- 1720929
- 2134285
- 9617297
- 3011818499
- 3017435639
- 3009165919
- 3009169996
- 2028632
- 3004748528
- 3011874600
- 3012401682
- 3011181154
- 3012329926
- 3006846753
- 3004153896
- 3007125392
- 9614841
- 3014655115
- 3006639944
- 1000200989
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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