510(k) K153273
- Device
- MySpine Pedicle Screw Placement Guides - LP
- Applicant
- Medacta International SA
- 510(k) number
- K153273
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-29
- Date received
- 2015-11-12
- 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
- Michael G Loiterman
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers#
- 3010123206
- 3011765094
- 3003525643
- 1824199
- 3013055499
- 3010370500
- 3006563559
- 3015876273
- 3014763043
- 3008114965
- 3001239363
- 3006082533
- 1000432246
- 3014252644
- 3023138345
- 3009631939
- 3010120104
- 1000461041
- 3009971621
- 1643817
- 3006272282
- 3011181154
- 1529009
- 3007014520
- 3010120339
- 8043792
- 3014680795
- 3005061536
- 3010365473
- 1834331
- 3005677016
- 3010326971
- 3009973505
- 2530808
- 3009468807
- 2183744
- 3016050940
- 3006128100
- 1531174
- 3007993775
- 3010160527
- 3009973699
- 3009144915
- 2133687
- 3005180920
- 1319429
- 3017036472
- 3010123256
- 2028632
- 3004153896
- 3015869121
- 2031966
- 3009049161
- 3006849754
- 3006846753
- 3008110533
- 3004788213
- 3010462278
- 3003855635
- 3011818499
- 1424434
- 3009732568
- 3043543260
- 2648623
- 3006217744
- 3003477135
- 3009169996
- 1649518
- 2183449
- 1530390
- 3015869493
- 3004188066
- 3008959459
- 3040335671
- 9616062
- 3012329926
- 3012491394
- 3031240334
- 3010097171
- 1835296
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 |
| 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 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases