510(k) K093170
- Device
- ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- Applicant
- SPINEART
- 510(k) number
- K093170
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-04
- Date received
- 2009-10-07
- 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
- FRANCK PENNESI
- Address
- Cointrin 20 Rte. De Pre-Bois Cp1813 Geneva CH 1215 1215
FDA Registration Numbers#
- 9617297
- 1226544
- 3023265483
- 3007993775
- 3007485169
- 3006846753
- 3011221483
- 3004111573
- 3010866843
- 1000493591
- 3009554293
- 3005819474
- 3006563559
- 2032830
- 3015869121
- 3043543260
- 3010370880
- 2531477
- 3036756245
- 3006404019
- 3034676720
- 1828288
- 3011556898
- 3015941638
- 3009882462
- 2133687
- 3008526708
- 3006217744
- 3016443334
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3010041993
- 1043214
- 3010120135
- 3008110533
- 3009169872
- 2032112
- 3031240334
- 3010407203
- 3014252644
- 1644312
- 1526439
- 1527105
- 1221763
- 3004774118
- 3008102042
- 2029275
- 9681465
- 3010041430
- 3009504230
- 1424263
- 3000170817
- 3007353762
- 3005562917
- 3016261131
- 3003935342
- 3009173317
- 3008959459
- 9614841
- 3012711663
- 3018210489
- 2032093
- 3025457095
- 3010509633
- 3020282716
- 2647346
- 3011390763
- 9610612
- 1000432246
- 3008868758
- 8020776
- 8043792
- 1835572
- 1724955
- 3008262872
- 3008749819
- 3005180920
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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