510(k) K121172
- Device
- REFORM PEDICLE SCREW SYSTEM
- Applicant
- SPINAL USA
- 510(k) number
- K121172
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-08
- Date received
- 2012-04-17
- 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
- J.D. WEBB
- Address
- 2050 Executive Dr.. Pear MS US 39208 39208
FDA Registration Numbers#
- 3009217531
- 3005497913
- 3010047454
- 1222773
- 3006639944
- 1226544
- 9681465
- 1833986
- 3009468807
- 3015398319
- 3006783837
- 3010120339
- 1000461041
- 3005819474
- 3019767615
- 3003477135
- 3004893332
- 3012447612
- 3023138345
- 3019878714
- 3005031160
- 3009971621
- 1225838
- 3013055499
- 3013491327
- 3010326971
- 3018094310
- 1043214
- 3011277306
- 3003855635
- 3015869493
- 3010407203
- 3001239363
- 3003525643
- 3008959459
- 3010370500
- 3012863589
- 3010123206
- 3008583793
- 3008992889
- 1720929
- 1835296
- 3003541440
- 3006791286
- 1224360
- 3010370554
- 3004142400
- 1423662
- 3004111573
- 3009173317
- 3009887475
- 3015860552
- 9611274
- 3010531060
- 3006128100
- 1319660
- 1828464
- 3006460162
- 3016438694
- 3010120104
- 3010663372
- 3017036472
- 3010197239
- 3011489618
- 3004788213
- 9617544
- 9617297
- 3005596514
- 3036756245
- 3008526708
- 3010049501
- 3009380063
- 3000170817
- 9612420
- 3014252644
- 3015876273
- 3007675554
- 3004638532
- 3015219237
- 3011556898
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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