510(k) K140359
- Device
- MAXIMIS SPINAL FIXATION SYSTEM
- Applicant
- VALOREM SURGICAL
- 510(k) number
- K140359
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-07
- Date received
- 2014-02-12
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK MOORE
- Address
- 111 Hill Rd. Douglassville PA US 19518 19518
FDA Registration Numbers#
- 3014273424
- 3009962553
- 3006563559
- 3014763043
- 3010365473
- 3008110533
- 3010041993
- 3010047454
- 3009049161
- 3012381896
- 2032521
- 1043653
- 3008868758
- 2028632
- 3014725904
- 3006378738
- 3010097171
- 2031966
- 3007887127
- 3010120148
- 3004024955
- 3020282716
- 3000170817
- 1220477
- 3009888740
- 3003761012
- 3008583793
- 9611274
- 3018210489
- 3010160527
- 3017528621
- 3016261131
- 3005031160
- 3006272282
- 3009417901
- 3015831087
- 3012120772
- 2135156
- 1527105
- 1835831
- 3009169996
- 1935627
- 1649379
- 2134285
- 1828464
- 1834331
- 3009941480
- 3006082533
- 1030489
- 3009217531
- 1424263
- 3008102042
- 3015941638
- 3009051471
- 3011874600
- 3017036472
- 9611390
- 3030412764
- 2032098
- 1529009
- 1833920
- 3004464325
- 3010440433
- 3009106092
- 3010057495
- 3004941535
- 3001239363
- 3007675554
- 3009468807
- 3010120135
- 1224360
- 3012329926
- 3002807112
- 3011489618
- 1319660
- 3007353762
- 3015399803
- 9617297
- 3006128100
- 1056553
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#
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