510(k) K061162
- Device
- BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
- Applicant
- APPLIED SPINE TECHNOLOGIES, INC.
- 510(k) number
- K061162
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-07-26
- Date received
- 2006-04-26
- 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
- MICHELE LUCEY
- Address
- 300 George St., Suite 511 New Haven CT US 06511 06511
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
- 3006846753
- 3008110533
- 3004788213
- 3010462278
- 3003855635
- 1424434
- 3009732568
- 3043543260
- 2648623
- 3006217744
- 3003477135
- 3009169996
- 2183449
- 1530390
- 3015869493
- 3004188066
- 3008959459
- 9616062
- 3012329926
- 3012491394
- 3031240334
- 3010097171
- 1835296
- 3009165919
- 1225838
- 3004142400
- 3008754074
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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