510(k) K010563
- Device
- END-TO-END AND SIDE-BY-SIDE CONNECTORS
- Applicant
- SPINAL CONCEPTS, INC.
- 510(k) number
- K010563
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-05-25
- Date received
- 2001-02-26
- 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 M HOOPER
- Address
- 12012 Technology Blvd., #100 Austin TX US 78727 78727
FDA Registration Numbers#
- 3010057495
- 3010370500
- 3006791286
- 1528646
- 1835831
- 1834379
- 3025603301
- 3000203391
- 3011181154
- 3015398319
- 3007887127
- 3006082533
- 3007353762
- 3009882675
- 1833986
- 3013011598
- 3010120135
- 2530808
- 3011818499
- 3012491394
- 9611813
- 9612277
- 3008132398
- 3004111573
- 3018210489
- 3040335671
- 3009973505
- 3009049161
- 3007345964
- 1424263
- 9616944
- 3008102042
- 3014252644
- 3004774118
- 2648623
- 3009169996
- 3036756245
- 1530390
- 2032830
- 3016438694
- 1643817
- 3031240334
- 3008285983
- 3004941535
- 1319660
- 3006404071
- 3010041993
- 3014273424
- 3004024955
- 1644312
- 3002808227
- 3009998573
- 3006639944
- 3004788213
- 1057425
- 3009165919
- 1220477
- 3015860552
- 2032112
- 9617544
- 1224360
- 2032098
- 3013055499
- 2183946
- 3007728266
- 3011796723
- 1834331
- 3010123256
- 3005226664
- 3009149199
- 9681642
- 1835572
- 3008749819
- 3006272282
- 9611390
- 9616062
- 3023852420
- 3011513267
- 1649518
- 3015869121
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#
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
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