510(k) K071743
- Device
- PILLAR PEDICLE SCREW SYSTEM
- Applicant
- THE 4TH COLUMN, LLC
- 510(k) number
- K071743
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-06
- Date received
- 2007-06-27
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID J COLLETTE
- Address
- 11234 El Camino Real Suite 200 San Diego CA US 92130 92130
FDA Registration Numbers#
- 3003541440
- 1834379
- 3004142400
- 9612420
- 3015212339
- 3010531060
- 1720929
- 3014763043
- 1000200989
- 1649379
- 3007353762
- 3005031160
- 1530390
- 3006783837
- 2032521
- 2031093
- 3012120772
- 3010197239
- 3010370500
- 3012711663
- 3010123256
- 3008526708
- 3008749819
- 3004717358
- 3010663372
- 3009631939
- 1417485
- 2530808
- 3008132398
- 3005180920
- 3015399803
- 2648623
- 3017036472
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3004111573
- 3010120326
- 2648666
- 3010049501
- 3009149199
- 3010032903
- 1221053
- 2531195
- 3010123206
- 3011796723
- 2133928
- 1835251
- 3014655115
- 3010365473
- 3010160527
- 2027467
- 3025603301
- 3000170817
- 1043214
- 3009217531
- 9615021
- 3016438694
- 2135156
- 1221763
- 3002808227
- 3008534770
- 1319660
- 1835831
- 3006017180
- 3010287685
- 3006272282
- 3010863450
- 3015440604
- 3009732568
- 3011390763
- 3007923096
- 3008198024
- 1724955
- 3014252644
- 3015219237
- 3006378738
- 8010944
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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