510(k) K081296
- Device
- PREFERENCE PEDICLE SCREW SYSTEM
- Applicant
- US SPINE
- 510(k) number
- K081296
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-06
- Date received
- 2008-05-07
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal 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 JANSEN, PHARM. D.
- Address
- 13540 Guild Ave. Apple Valley MN US 55124 55124
FDA Registration Numbers#
- 1935627
- 3007728266
- 3009468807
- 3009509485
- 3008812560
- 1000493591
- 3007993775
- 3009882462
- 3005739886
- 3004024955
- 3010509633
- 3010365473
- 1835572
- 3005180920
- 1424434
- 3016438694
- 3011556898
- 3015941638
- 3023138345
- 3005819474
- 3020282716
- 3010663372
- 3010440433
- 3007922509
- 1223434
- 3009169996
- 3012711663
- 9611827
- 3010120135
- 3008959459
- 3008868758
- 3014252644
- 1828288
- 3009165919
- 1834331
- 3007485169
- 3010041499
- 1057425
- 3043543260
- 3010370880
- 3005677016
- 2133928
- 1824199
- 3009962553
- 3008455034
- 3005325790
- 3016496998
- 3008114965
- 3009149199
- 3000170817
- 3008534770
- 3010009693
- 3012447612
- 3012120772
- 2183744
- 2648623
- 3009417901
- 9611813
- 3012863589
- 3005874553
- 8010944
- 3006984710
- 3009110133
- 9612420
- 3010120104
- 3004638600
- 2183449
- 3025457095
- 3009971621
- 1835444
- 3009973505
- 1835831
- 3023852420
- 3039103971
- 1319660
- 3006460162
- 3008198024
- 8043792
- 3010197239
- 1043653
Source Documents#
Other 510(k) Records For Product Code MNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 |
Legacy Summary#
summary
FDA Review#
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