510(k) K173022
- Device
- SeaSpine Ventura NanoMetalene System
- Applicant
- SeaSpine Orthopedics Corporation
- 510(k) number
- K173022
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-26
- Date received
- 2017-09-28
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Gina Flores
- Address
- 5770 Armada Dr. Carlsbad CA US 92008 92008
FDA Registration Numbers
- 3015709929
- 1450662
- 3021006165
- 3013820501
- 3010763958
- 2027062
- 3013393446
- 3015487912
- 3014252644
- 3004464325
- 2183744
- 3023852420
- 1834331
- 3009962553
- 1833824
- 3002807112
- 2032521
- 2031093
- 3009404219
- 3009504230
- 1219655
- 3036503733
- 3000170817
- 1319660
- 3017521423
- 3021945817
- 3012429289
- 3009756327
- 3010863450
- 3019767615
- 3012028003
- 3033739814
- 3006128100
- 3019837678
- 1030489
- 3004719693
- 3031081659
- 1649379
- 2183449
- 1723170
- 1060840
- 3004024955
- 3012120772
- 3005751028
- 3017048829
- 3009189869
- 3005083075
- 3009887475
- 9616680
- 3023138345
- 3010047454
- 3013546462
- 3014315669
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 3012447612
- 9611827
- 2531195
- 3006017180
- 3016237080
- 1835296
- 3007887127
- 3003898943
- 3008599979
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3020307303
- 3004893332
- 1833986
- 3009988302
- 1528646
- 1722511
- 3011181154
- 3036042032
- 3009132077
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889981211981 | Specials | SEASPINE ORTHOPEDICS CORPORATION | 2020-09-24 |
| 10889981152147 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152000 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152017 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152024 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152031 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152048 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152055 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152062 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152079 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152086 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152093 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152109 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152116 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152123 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152130 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152291 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152154 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152161 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152178 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152185 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152192 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152208 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152215 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152222 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152239 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152246 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152253 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152260 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
| 10889981152277 | Ventura NanoMetalene System | SEASPINE ORTHOPEDICS CORPORATION | 2017-11-17 |
Legacy Summary
summary
FDA Review
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